Overall, the objective of this pilot study is to utilize the IL-6 receptor antagonist tocilizumab to prospectively evaluate the role of IL-6 in the antidepressant and immunological effects of whole body hyperthermia (WBH). The study seeks to replicate findings thus far that WBH has an antidepressant effect by administering the intervention at a site not involved in studies to date. Moreover, the current proposal may help the investigators better understand the role of IL-6 in the pathogenesis and treatment of depression which might point to novel immune-based interventions for Major Depressive Disorder (MDD). Finally, the current proposal holds promise for better understanding of a novel treatment for MDD, which is among the leading causes of health-related disability in the world.

Start Date01 Dec 2026

Sponsor / Collaborator

The General Hospital Corp.

[+1]

KCT0011665

/ Not yet recruitingNot ApplicableIIT

Exploratory Observational Study to Evaluate the Quality of Life, Safety, and Efficacy of Outpatient-Based Prophylactic Tocilizumab Combination with Bispecific Antibody Administration in Patients with Relapsed/Refractory Multiple Myeloma.

Start Date09 Jun 2026

Sponsor / Collaborator-

NCT06381661

/ Not yet recruitingPhase 2IIT

PALETTE- Adaptive Platform Trial for Personnalisation of Sepsis Treatment in Children and Adults: a Multi-national, Treatable Traits-guided, Adaptive, Exploratory, Bayesian Basket Trial

PALETTE is a perpetual adaptive platform to efficiently study sepsis interventions within 'treatable traits' in all-ages patients enabling prompt evaluation of pandemic treatments. Treatable traits, therapeutic targets identified by phenotypes or endotypes (defined by biological mechanism or by treatment response) through validated biomarkers (measurable characteristic reflecting normal or pathogenic processes, or treatment responses), may include multi-omics, cellular, immune, metabolic, endocrine features, or intelligent algorithms. PALETTE Bayesian adaptive design enables parallel investigations of multiple interventions for sepsis, and quick inclusion of pandemic pathogens. PALETTE's new conceptual model will respond to the challenges of standard approaches, i.e. series of sepsis trials, each investigating one or two interventions, expensive, time consuming, and inappropriate in pandemic context.

Start Date01 May 2026

Sponsor / Collaborator

Assistance Publique des Hôpitaux de Paris SA

100 Clinical Results associated with Tocilizumab

100 Translational Medicine associated with Tocilizumab

100 Patents (Medical) associated with Tocilizumab

7,016

Literatures (Medical) associated with Tocilizumab

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Costs per responder for patients with relapsed or refractory multiple myeloma treated with Talquetamab compared with usual care

Article

Author: Mu, Fan ; Patel, Neel ; Yang, Chelsey ; Jiao, Tianze ; Liu, Yi-Hsuan ; Lee, Hans C. ; Zhang, Xinke ; Grajales-Cruz, Ariel F. ; Wang, Jiamin ; Goble, Joseph

AIMS:

To evaluate costs per responder for patients with triple-class exposed (TCE) relapsed or refractory multiple myeloma (RRMM) receiving talquetamab (Tal) on weekly (QW) and biweekly (Q2W) dosing schedules, compared with usual care from a United States commercial payer's perspective.

METHODS:

A cost per responder model was developed over a 6-month time horizon, incorporating pre-progression and post-progression costs. For Tal QW and Tal Q2W, pre-progression costs included costs of drug acquisition, inpatient step-up doses (hospitalization, pre-medication, and tocilizumab), outpatient visits, and monitoring. Pre-progression costs for usual care were estimated based on a weighted average of the 10 most used regimens in a real-world LocoMMotion/MoMMent study, including costs of acquisition, administration, co-medication, and monitoring. Post-progression costs included subsequent treatment for a subset of patients and terminal care costs prior to death. All costs were reported in 2025 United States Dollars. Clinical data of overall response rate (ORR), progression-free survival, and overall survival were obtained from an indirect treatment comparison using MonumenTAL-1 (September 2024 data cut) and LocoMMotion/MoMMent (October 2022 and August 2023 data cuts) as data sources. Deterministic sensitivity analyses and scenario analyses were conducted to assess the robustness of model results.

RESULTS:

Over the 6-month period, the total cost of care was $179,556 for usual care, $295,993 for Tal QW, and $315,135 for Tal Q2W. Despite higher costs, Tal demonstrated superior ORR, resulting in lower cost per responder: $575,962 for usual care, $405,470 for Tal QW, and $443,165 for Tal Q2W, representing a 23-30% reduction in cost per responder with Tal. Sensitivity and scenario analyses showed consistent findings.

CONCLUSION:

Although Tal QW and Q2W are associated with higher total per-patient costs compared with usual care, they offer improved clinical effectiveness, resulting in lower cost per responder. These findings suggest greater economic value for Tal in the treatment of TCE RRMM.

01 Jul 2026·JOINT BONE SPINE

Tapering or stopping tocilizumab in PMR: Toward optimized treatment withdrawal

Author: Devauchelle-Pensec, Valérie ; Chevet, Baptiste

01 Jun 2026·MOLECULAR ASPECTS OF MEDICINE

Dual-targeting strategies for cancer and diabetes: Converging pharmacological pathways and repurposed therapies

Review

Author: Sehrawat, Abhishek ; Bhatti, Jasvinder Singh ; Bhatti, Gurjit Kaur ; Ahmed, Ishtiaq ; Kaura, Kawaljit Singh ; Kandimalla, Ramesh ; Sharma, Pushpender Kumar

The rising global burden of cancer and diabetes mellitus, particularly type 2 diabetes (T2DM), underscores a critical need for integrated therapeutic strategies. Epidemiological studies reveal a compelling bidirectional association between these diseases, with T2DM increasing cancer risk and adversely affecting cancer prognosis. Shared pathophysiological mechanisms including insulin/IGF-1 signaling, chronic low-grade inflammation, oxidative stress, and metabolic reprogramming serve as potential therapeutic convergence points. This review explores the mechanistic and clinical basis for dual-targeting strategies that address both malignancy and metabolic dysfunction simultaneously. Key molecular intersections include the PI3K/Akt/mTOR and AMPK pathways, which are central to cell proliferation, survival, and glucose metabolism. Pharmacological agents like metformin, SGLT2 inhibitors, and statins demonstrate promising anticancer effects in addition to glycemic control, while biologics such as canakinumab and tocilizumab modulate inflammatory processes relevant to both disease states. Natural compounds including curcumin, resveratrol, and berberine exhibit dual benefits via antioxidant, anti-inflammatory, and metabolic pathways. The review critically evaluates preclinical studies, retrospective cohort analyses, and clinical trial data supporting the repurposing of anti-diabetic agents for oncology indications. Despite mixed outcomes in large-scale trials, evidence suggests biomarker-based patient selection may enhance therapeutic efficacy. Moreover, emerging paradigms including immunometabolism, gut microbiota modulation, and gene-based interventions offer promising frontiers for integrated care. Ultimately, dual-targeting strategies represent an emerging and promising therapeutic framework for managing patients with overlapping cancer and metabolic disease, with potential to optimize outcomes, reduce therapy-related toxicities, improve long-term survival. Future research must prioritize biomarker-guided precision therapies, multidisciplinary management and the inclusion of metabolic parameters in oncology trial designs.

290

News (Medical) associated with Tocilizumab

16 Apr 2026

·allsci.com

University Hospital Erlangen achieves CD19 CAR-T remission in autoimmune hemolytic anemia with ITP

Researchers at University Hospital Erlangen in Erlangen, Germany report that a single infusion of CD19 CAR-T therapy in autoimmune hemolytic anemia produced sustained remission in a patient with overlapping refractory AIHA, immune thrombocytopenia, and antiphospholipid syndrome, according to a study published April 10, 2026 in Med. The patient had failed nine prior treatment lines, including three courses of rituximab. The case involved a 47-year-old woman with concurrent cold- and warm-agglutinin autoimmune hemolytic anemia, ITP, and antiphospholipid antibody syndrome — a combination of autoantibody-driven disorders sharing a common pathogenic mechanism in dysregulated B cells. Prior therapies including steroids, intravenous immunoglobulin, azathioprine, bortezomib, and repeated rituximab had each failed to produce durable control. The treating team at Erlangen administered zorpocabtagene-autoleucel (Zorpo-cel; MB-CART19.1), an autologous 4-1BB-costimulated CD19-directed CAR-T cell product manufactured on the Miltenyi Prodigy platform, at a dose of 1 × 10⁶ CAR-positive T cells per kilogram following lymphodepletion with fludarabine and cyclophosphamide. Hematologic recovery was rapid. The patient achieved transfusion independence by day 7 and hemoglobin normalization above 12 g/dL by day 25. Hemolysis markers including LDH and haptoglobin normalized, and reticulocyte counts stabilized. Warm-reactive autoantibodies became undetectable, cold agglutinin titers fell, and antiphospholipid antibodies declined. Platelet counts improved without additional ITP-directed therapy. These responses were maintained across the 11-month follow-up period. The direct antiglobulin test showed conversion, and CAR-T cells demonstrated in vivo expansion detectable in peripheral blood following infusion. At approximately day 322, reconstituted B cells were 98% naïve phenotype, indicating that the reconstituting immune compartment lacked the autoreactive memory imprinting present before treatment. The safety profile was consistent with CAR-T cell therapy autoimmune hemolytic anemia experience in oncology settings. The patient developed Grade 1–2 cytokine release syndrome managed with tocilizumab and supportive care. No immune effector cell-associated neurotoxicity syndrome was observed. Hypogammaglobulinemia, an expected consequence of B cell depletion, was managed with immunoglobulin replacement. No treatment-related mortality or life-threatening infections occurred. The biological rationale for CD19-directed CAR-T cells in this setting centers on the shared dependence of AIHA, ITP, and antiphospholipid syndrome on autoreactive B cells producing pathogenic autoantibodies. CD19 is expressed across the B cell lineage, including on subsets and in tissue compartments where the anti-CD20 monoclonal antibody rituximab achieves incomplete penetration. The Erlangen authors note that CAR-T cells achieved remission despite three prior rituximab failures, consistent with the hypothesis that deeper and more anatomically complete B cell depletion — including in lymph nodes and mucosal compartments — underlies the more durable response. The 4-1BB costimulatory domain incorporated into Zorpo-cel is associated with enhanced CAR-T cell persistence and memory differentiation, which may contribute to the duration of response observed. The authors describe the qualitative change in the reconstituted B cell compartment as a key mechanistic finding. The near-complete naïve phenotype of returning B cells at day 322 suggests that pathogenic memory clones were eliminated and that immune reconstitution proceeded from progenitors without the autoimmune programming that had driven disease. The authors characterize this as a B cell reset rather than simple depletion, distinguishing the approach from conventional immunosuppression, which does not eliminate autoreactive memory. The Erlangen group has previously reported CD19 CAR-T outcomes in systemic lupus erythematosus, inflammatory myositis, and systemic sclerosis, establishing the broader concept of CAR-T-mediated immune reset in connective tissue diseases. The current report extends that work to autoimmune cytopenias — a distinct disease category where dedicated CAR-T data remain limited. Refractory AIHA treatment options after rituximab failure are constrained. Fostamatinib, a spleen tyrosine kinase inhibitor, carries regulatory approval for warm AIHA but does not address the underlying autoantibody mechanism. Sutimlimab targets complement component C1s and is approved specifically for cold agglutinin disease but does not eliminate pathogenic B cells. Thrombopoietin receptor agonists for ITP and anticoagulation for antiphospholipid syndrome address downstream consequences without modifying the autoimmune source. In the commercial CAR-T space, Kyverna Therapeutics is advancing KYV-101, a CD19-directed autologous CAR-T product, in Phase II trials across multiple autoimmune indications including multiple sclerosis, myasthenia gravis, and systemic sclerosis. Cabaletta Bio is running Phase I/II RESET trials with CABA-201 in inflammatory myositis and lupus. Neither program is specifically focused on autoimmune cytopenias, and the current report from Erlangen represents one of the few published accounts of antiphospholipid syndrome CAR-T treatment alongside AIHA and ITP in a single patient. Prof. Dr. Fabian Müller of University Hospital Erlangen served as corresponding author. The work was funded by the Deutsche Forschungsgemeinschaft, Deutsche Krebshilfe, the Bundesministerium für Bildung und Forschung, the Bayerisches Zentrum für Krebsforschung, the Interdisciplinary Center for Clinical Research Erlangen, and the Staedtler Foundation. Miltenyi Biotechnology provided the manufacturing platform and research support to authors at the institution. Meta description: Erlangen researchers report CD19 CAR-T remission in refractory autoimmune hemolytic anemia with concurrent ITP and antiphospholipid syndrome. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

10 Apr 2026

·www.biospace.com

CMS Grants Fresenius Kabi COVID-19 Indication-Specific HCPCS Codes for Tyenne® (tocilizumab-aazg)

Effective for Medicare claims beginning April 1, 2026 LAKE ZURICH, Ill.--(BUSINESS WIRE)-- #CommittedToLife --Fresenius Kabi, a part of Fresenius, and a leading provider of essential medicines and medical technologies, announced today that the Centers for Medicare & Medicaid Services has issued indication-specific Healthcare Common Procedure Coding System (HCPCS) codes for Tyenne ® (tocilizumab-aazg) for the treatment of COVID-19. The new codes will be effective for Medicare claims for eligible patients administered Tyenne on April 1, 2026. These new COVID-19 HCPCS codes – Q0238 for injection, M0233 for intravenous infusion first-dose, and M0234 for intravenous infusion second-dose – will support billing and reimbursement for Tyenne when used in the treatment of COVID-19 in appropriate patients, consistent with its FDA-approved labeling. “Fresenius Kabi’s indication-specific codes for COVID-19 represent an important step in supporting provider access and streamlined reimbursement for Tyenne,” said Molly Benson, senior vice president, Biopharma, at Fresenius Kabi USA. “Clear coding helps facilitate efficient claims processing and reinforces our commitment to ensuring patients have access to important treatment options.” HCPCS codes are reimbursement codes used by healthcare providers and payers to process claims for drugs administered by injection, infusion, or other methods. These codes are used by Medicare, Medicaid, and commercial insurers to standardize claims submissions and reimbursement processes. Tyenne previously received a permanent, product-specific Q-code for its approved autoimmune indications. These indication-specific COVID-19 codes further support appropriate coding and reimbursement pathways across care settings. To learn more about how Fresenius Kabi provides comprehensive patient support, visit the KabiCare™ patient services hub . To learn more about Tyenne, please visit . About Tyenne ® , a tocilizumab biosimilar Tyenne ® (tocilizumab-aazg), a biosimilar to Actemra ® (tocilizumab), is a prescription medicine called an Interleukin-6 (IL-6) receptor antagonist. It was developed by Fresenius Kabi using advanced analytical and manufacturing technologies for use in the treatment of several autoimmune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial, invasive fungal, viral, and other opportunistic infections have occurred in patients receiving the product. Tyenne is contraindicated in patients with known hypersensitivity to tocilizumab products. For more information about Tyenne, please see the full prescribing information for the U.S. here , including Boxed Warning. IMPORTANT SAFETY INFORMATION RISK OF SERIOUS INFECTIONS Patients treated with Tyenne ® (tocilizumab-aazg) are at increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis (TB), bacterial, invasive fungal, viral, or other opportunistic infections. If a serious infection develops, interrupt Tyenne until the infection is controlled. Reported infections include: Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients, except those with COVID-19, should be tested for latent tuberculosis before Tyenne use and during therapy (except patients with COVID-19). Treatment for latent infection should be initiated prior to Tyenne use. Invasive fungal infections, including candidiasis, aspergillosis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease. Bacterial, viral and other infections due to opportunistic pathogens. The risks and benefits of treatment with Tyenne should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Tyenne, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. CONTRAINDICATION Tyenne is contraindicated in patients with known hypersensitivity to tocilizumab products. WARNINGS AND PRECAUTIONS COVID-19: Monitor for signs and symptoms of new infections during and after treatment with Tyenne in patients with COVID-19. Limited information is available regarding the use of Tyenne in patients with COVID-19 and concomitant serious active infections. The risks and benefits of treatment with Tyenne in patients with COVID-19 and other concurrent infections should be considered. Gastrointestinal Perforations: Events of gastrointestinal (GI) perforation have been reported in clinical trials, primarily as complications of diverticulitis in RA patients. Use Tyenne with caution in patients who may be at increased risk for GI perforation. Promptly evaluate patients presenting with new-onset abdominal symptoms for early identification of GI perforation. Hepatotoxicity: Serious cases of hepatic injury have been observed in patients taking intravenous or subcutaneous tocilizumab. Some of these cases have resulted in liver transplant or death. Time to onset for cases ranged from months to years after treatment initiation. Most cases presented with marked elevations of transaminases (> 5 times ULN), and some cases presented with signs or symptoms of liver dysfunction and only mildly elevated transaminases. Treatment with Tocilizumab was associated with a higher incidence of transaminase elevations; increased frequency and magnitude of these elevations were observed when tocilizumab was used in combination with potentially hepatotoxic drugs (e.g., methotrexate). It is not recommended to initiate Tyenne treatment in RA, GCA, PJIA, and SJIA patients with elevated transaminases ALT or AST greater than 1.5x ULN. In patients who develop elevated ALT or AST greater than 5x ULN discontinue Tyenne. Patients who are hospitalized with COVID-19 may have elevated AST or ALT levels. Multiorgan failure with involvement of the liver is recognized as a complication of severe COVID-19. The decision to administer Tyenne should balance the potential risks of acute treatment with Tyenne against the potential benefit of treating COVID-19. It is not recommended to initiate TYENNE treatment in COVID-19 patients with elevated ALT or AST above 10x ULN. Monitor ALT and AST during treatment. Measure liver tests promptly in patients who report symptoms that may indicate liver injury. If the patient is found to have abnormal liver tests, Tyenne treatment should be interrupted. Tyenne should only be restarted in patients with another explanation for the liver test abnormalities after normalization of the liver tests. Laboratory Parameters: Laboratory monitoring is recommended due to potential consequences of treatment-related laboratory abnormalities in neutrophils, platelets, lipids, and liver function tests. Dosage modifications may be required. Neutropenia: Treatment with tocilizumab products was associated with a higher incidence of neutropenia. It is not recommended to initiate Tyenne treatment in RA, GCA, PJIA, and SJIA patients with a low neutrophil count i.e., absolute neutrophil count (ANC) less than 2000 per mm 3 . In patients who develop an ANC less than 500 per mm 3 treatment is not recommended. It is not recommended to initiate Tyenne treatment in COVID-19 patients with an ANC less than 1000 per mm 3 . Neutrophils should be monitored. Thrombocytopenia: Treatment with tocilizumab products was associated with a reduction in platelet counts. It is not recommended to initiate Tyenne in RA, GCA, PJIA, and SJIA patients with a platelet count below 100,000 per mm 3 . In patients who develop a platelet count less than 50,000 per mm 3 , treatment is not recommended. It is not recommended to initiate Tyenne treatment in COVID-19 patients with a platelet count less than 50000 per mm 3 . Platelets should be monitored. Elevated Liver Enzymes: It is not recommended to initiate Tyenne treatment in patients with elevated transaminases ALT or AST >1.5x ULN. In patients who develop elevated ALT or AST >5x ULN, treatment is not recommended. Lipid Abnormalities: Treatment with tocilizumab products was associated with increases in lipid parameters such as total cholesterol, triglycerides, LDL cholesterols, and/or HDL cholesterol. Immunosuppression: The impact of treatment with tocilizumab products on the development of malignancies is not known, but malignancies were observed in clinical studies with tocilizumab. Tyenne is an immunosuppressant, and treatment with immunosuppressants may result in an increased risk of malignancies. Hypersensitivity Reactions : Hypersensitivity reactions, including anaphylaxis, have been reported in association with tocilizumab and anaphylactic events with a fatal outcome have been reported with intravenous infusion of Tocilizumab. Additionally, serious cutaneous reactions, including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported in patients with autoinflammatory conditions treated with Tocilizumab products. Tyenne for intravenous use should only be infused by a healthcare professional with appropriate medical support to manage anaphylaxis. For Tyenne subcutaneous injection, advise patients to seek immediate medical attention if they experience any symptoms of a hypersensitivity reaction. If anaphylaxis or other hypersensitivity reaction occurs, stop administration of Tyenne immediately and discontinue Tyenne permanently. Do not administer Tyenne to patients with known hypersensitivity to Tyenne. Demyelinating Disorders: The impact of treatment with tocilizumab products on demyelinating disorders is not known, but multiple sclerosis and chronic inflammatory demyelinating polyneuropathy were reported rarely in clinical studies. Monitor patients for signs and symptoms of demyelinating disorders. Prescribers should exercise caution in considering the use of Tyenne in patients with preexisting or recent-onset demyelinating disorders. Active Hepatic Disease and Hepatic Impairment: Treatment with Tyenne is not recommended in patients with active hepatic disease or hepatic impairment. Vaccinations : Avoid use of live vaccines concurrently with Tyenne. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving Tyenne or on the effectiveness of vaccination in patients receiving Tyenne. Patients should be brought up to date on all recommended vaccinations prior to initiation of Tyenne therapy, if possible. ADVERSE REACTIONS Most common adverse reactions (incidence of at least 5%): upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, injection site reactions. DRUG INTERACTIONS In GCA patients, no effect of concomitant corticosteroid on tocilizumab exposure was Observed. Cytochrome P450s in the liver are down-regulated by infection and inflammation stimuli including cytokines such as IL-6. Inhibition of IL-6 signaling in RA patients treated with Tyenne may restore CYP450 activities to higher levels than those in the absence of Tyenne leading to increased metabolism of drugs that are CYP450 substrates. Exercise caution when co-administering Tyenne with CYP3A4 substrate drugs where decrease in effectiveness is undesirable, e.g., oral contraceptives, lovastatin, atorvastatin, Etc. USE IN PREGNANCY The limited available data with tocilizumab products in pregnant women are not sufficient to determine whether there is a drug-associated risk for major birth defects and miscarriage, or other adverse maternal or fetal outcomes. You may report side effects to the FDA at (800) FDA-1088 or . You may also report side effects to Fresenius Kabi at (800) 551-7176. INDICATIONS Tyenne is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Tyenne is indicated for the treatment of giant cell arteritis (GCA) in adult patients. Tyenne is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older. Tyenne is indicated for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients 2 years of age and older. Tyenne is indicated for the treatment of chimeric antigen receptor (CAR)-T cell-induced severe or life-threatening cytokine release syndrome in adults and pediatric patients 2 years of age and older. Tyenne is indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adult patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Please see additional Important Safety Information in full Prescribing Information , including BOXED WARNING . About Fresenius Kabi As a global healthcare company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of patients with critical and chronic conditions. With more than 41,000 employees and present in more than 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to essential medicines and technologies. In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is a global leader in supplying blood collection bags and devices, supporting blood banks and health care facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care. Fresenius Kabi takes a holistic approach to health care and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of 450 million patients annually. With the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of healthcare. Fresenius Kabi is part of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale. For more information, please visit . To learn about U.S. career opportunities at Fresenius Kabi, visit us at and follow us on LinkedIn and Facebook . This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius Kabi does not undertake any responsibility to update the forward-looking statements in this release. Contacts Media contact Joanie Clougherty (614) 717-5741 Joan.Clougherty@fresenius-kabi.com

Drug Approval

27 Mar 2026

·allsci.com

Researchers report first data for AZ’s in vivo CAR-T cell in myeloma patients

Investigators in China report that a single intravenous infusion of ESO-T01, a nanobody-directed lentiviral vector linked to AstraZeneca, generated functional anti-BCMA CAR-T cells directly inside patients with relapsed or refractory multiple myeloma, bypassing the need for ex vivo cell manufacturing, according to a Phase I study published in Nature Medicine. The in vivo CAR-T approach produced objective responses in four of five treated patients, including three stringent complete remissions, without lymphodepleting chemotherapy or leukapheresis. The ESO-T01 clinical trial (NCT06791681), conducted at sites including Tongji Hospital and Union Hospital in Wuhan, enrolled five consecutively treated male patients with a median of three prior lines of therapy. A second Phase I study (NCT06691685) is also recruiting at Union Hospital. Full author affiliations and the corporate sponsor were not disclosed in the available abstract, though the proprietary product designation suggests involvement of a biotechnology company responsible for the vector’s development. Single infusion replaces weeks of manufacturing The study tested ESO-T01 at a dose of 0.2 × 10⁹ transduction units delivered as a single intravenous infusion. The vector is an immune-shielded lentiviral particle engineered with surface nanobodies that redirect its tropism to circulating T cells. Upon binding, the vector delivers a humanized anti-BCMA chimeric antigen receptor transgene that integrates into the T cell genome, converting the patient’s own T cells into CAR-T cells without removing them from the body. This approach eliminates three steps that define conventional CAR-T cell generation: leukapheresis to collect patient T cells, weeks-long ex vivo manufacturing at centralized facilities, and lymphodepleting chemotherapy conditioning prior to reinfusion. In the current study, patients received ESO-T01 without any of these interventions. CAR-positive T cells were detectable in peripheral blood as early as day 7 post-infusion, with peak expansion around days 10 to 14. Both CD4-positive and CD8-positive CAR-T cell populations were generated. The cells persisted throughout the follow-up period, which extended to approximately six months. Responses deepened over time in pretreated population Four of five patients achieved objective responses. Three reached stringent complete remission and one achieved very good partial response. Responses deepened over time, with patients progressing sequentially from partial response to deeper remission categories. All four evaluable responders achieved minimal residual disease negativity at a sensitivity threshold of 10⁻⁵ by day 60, and all maintained that status at last follow-up. Soluble BCMA levels declined to the normal range in responders, consistent with elimination of malignant plasma cells. One patient died before the first efficacy assessment due to spinal cord compression from progressive extramedullary myeloma. The investigators attributed this event to underlying disease rather than to ESO-T01. At a median follow-up of 6.0 months, all responses remained ongoing. No formal statistical comparisons were performed given the sample size of five patients. Safety profile No dose-limiting toxicities occurred at the tested dose. Cytokine release syndrome developed in four of five patients, but all events were grade 1 or grade 2 and were managed with standard supportive care, including tocilizumab in some cases. No immune effector cell-associated neurotoxicity syndrome was observed in any patient, a finding that contrasts with the approximately 10 to 20 percent incidence reported with approved ex vivo anti-BCMA CAR-T products such as idecabtagene vicleucel and ciltacabtagene autolcel. No severe or unexpected infections were reported. The absence of lymphodepleting chemotherapy in the treatment protocol preserved baseline immune function, which may have contributed to the infection profile. The investigators reported no evidence of insertional oncogenesis or off-target transduction of non-T cell lineages. The in vivo CAR-T landscape ESO-T01 was discovered by Belgium-based EsoBiotec and acquired by AstraZeneca in a March 2025 deal worth up to USD 1 billion. Multiple companies are pursuing in vivo CAR-T therapy through different delivery platforms. Umoja Biopharma has initiated a Phase I trial of UB-VV100, a lentiviral-based in vivo CAR-T targeting CD19 for B-cell malignancies. Capstan Therapeutics, acquired by Roche in 2024, is developing lipid nanoparticle-based mRNA delivery to T cells, an approach that produces transient rather than stable CAR expression. Kelonia Therapeutics, Orna Therapeutics, and Interius BioTherapeutics are pursuing related platforms at the preclinical stage. The approved multiple myeloma treatment landscape already includes two ex vivo anti-BCMA CAR-T products — idecabtagene vicleucel from BMS/2seventy bio and ciltacabtagene autolcel from Janssen/Legend Biotech — along with BCMA-targeting bispecific antibodies teclistamab and elranatamab. Bispecific antibodies are off-the-shelf and address the same accessibility problem that in vivo approaches aim to solve, but they require continuous dosing and have not demonstrated the depth of remission associated with CAR-T therapy. Several allogeneic CAR-T programs targeting BCMA, including Caribou Biosciences’ CB-011 and programs from Allogene Therapeutics and Poseida Therapeutics, are also in early clinical development. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Clinical ResultImmunotherapyPhase 1Cell Therapy

100 Deals associated with Tocilizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D02596	Tocilizumab	L04AC07	DB06273

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Interstitial lung disease due to systemic disease	United States	Genentech, Inc.	04 Mar 2021
Still's Disease, Adult-Onset	Japan	Chugai Pharmaceutical Co., Ltd.	22 May 2019
Takayasu Arteritis	Japan	Chugai Pharmaceutical Co., Ltd.	25 Aug 2017
COVID-19	European Union	Roche Registration GmbH	16 Jan 2009
COVID-19	Iceland	Roche Registration GmbH	16 Jan 2009
COVID-19	Liechtenstein	Roche Registration GmbH	16 Jan 2009
COVID-19	Norway	Roche Registration GmbH	16 Jan 2009
Cytokine Release Syndrome	European Union	Roche Registration GmbH	16 Jan 2009
Cytokine Release Syndrome	Iceland	Roche Registration GmbH	16 Jan 2009
Cytokine Release Syndrome	Liechtenstein	Roche Registration GmbH	16 Jan 2009
Cytokine Release Syndrome	Norway	Roche Registration GmbH	16 Jan 2009
Giant Cell Arteritis	European Union	Roche Registration GmbH	16 Jan 2009
Giant Cell Arteritis	Iceland	Roche Registration GmbH	16 Jan 2009
Giant Cell Arteritis	Liechtenstein	Roche Registration GmbH	16 Jan 2009
Giant Cell Arteritis	Norway	Roche Registration GmbH	16 Jan 2009
Juvenile Idiopathic Arthritis	European Union	Roche Registration GmbH	16 Jan 2009
Juvenile Idiopathic Arthritis	Iceland	Roche Registration GmbH	16 Jan 2009
Juvenile Idiopathic Arthritis	Liechtenstein	Roche Registration GmbH	16 Jan 2009
Juvenile Idiopathic Arthritis	Norway	Roche Registration GmbH	16 Jan 2009
Oligoarticular Arthritis	European Union	Roche Registration GmbH	16 Jan 2009

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hypoxic respiratory failure	Phase 3	United States	Genentech, Inc.	20 Apr 2020
Polymyalgia Rheumatica	Phase 3	France	-	06 Oct 2017
Osteoarthritis	Phase 3	France	Hoffmann-La Roche, Inc.	20 Nov 2015
Pain	Phase 3	France	Hoffmann-La Roche, Inc.	20 Nov 2015
Inflammation	Phase 3	Denmark	Hoffmann-La Roche, Inc.	28 May 2014
Inflammation	Phase 3	Finland	Hoffmann-La Roche, Inc.	28 May 2014
Inflammation	Phase 3	Norway	Hoffmann-La Roche, Inc.	28 May 2014
Inflammation	Phase 3	Sweden	Hoffmann-La Roche, Inc.	28 May 2014
Scleroderma, Systemic	Phase 3	United States	Hoffmann-La Roche, Inc.	01 Mar 2012
Scleroderma, Systemic	Phase 3	Canada	Hoffmann-La Roche, Inc.	01 Mar 2012

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02929251 (Pubmed \| Am J Ophthalmol)	Phase 2	Non-infectious posterior uveitis	112	adalimumab	hogcuhktmh(kljunijzhk) = oopucpkxmo bansdqkovg (ebdxifvdve ) View more	Positive	01 May 2026
				Tocilizumab	hogcuhktmh(kljunijzhk) = ssiadirstx bansdqkovg (ebdxifvdve ) View more
NCT06238024 (Pubmed \| EBioMedicine)	Phase 2	Ischemic stroke	108	Tocilizumab	veuermvots(kdyhdeqefk) = eixfqstnfv ziefhxoruh (coboslrunv, 3.4 - 20.6) View more	Positive	01 Mar 2026
				Placebo	veuermvots(kdyhdeqefk) = gptjimgggd ziefhxoruh (coboslrunv, 7.6 - 62.4) View more
Tandem Meetings ASTCT and CIBMTR2026	Not Applicable	Relapse multiple myeloma	10	Tocilizumab + Tocilizumab	xkaxghonex(aqzkcikixp) = werwsvyidi vfecvhvygc (insiwekcus ) View more	Positive	04 Feb 2026
Tandem Meetings ASTCT and CIBMTR2026	Not Applicable	Refractory Multiple Myeloma	7	Tocilizumab	nfkheylesq(ancgzxcbmo) = aynjqucwij nebaywzqyn (ncopapkzgn )	Positive	04 Feb 2026
ASH2025	Not Applicable	Multiple Myeloma	580	Talquetamab with Tocilizumab	kbctoibpkt(kvdxpqhqod) = otnxcuxsry gkrvwgejxb (bezjzzcyfg ) View more	Negative	06 Dec 2025
				Talquetamab without Tocilizumab	kbctoibpkt(kvdxpqhqod) = oloixxxwde gkrvwgejxb (bezjzzcyfg ) View more
ASH2025	Not Applicable	Relapse multiple myeloma	64	Tocilizumab 4 mg/kg	oneoqsiior(xgupbwchhj) = qfucfwyfla yqhwrbyovi (mmoanzpcaw, 10.7 - 37.8) View more	Positive	06 Dec 2025
				No Tocilizumab	oneoqsiior(wzfwsljqmu) = xwaehmzyja nylfqkekwu (hnzitjinpe ) View more
NCT04375228 (SITC2025)	Phase 2	Drug-Related Side Effects and Adverse Reactions	6	Tocilizumab	saldpderby(pbkfxgphzv) = Tocilizumab was well tolerated; no unexpected adverse events occurred. gqjkieuvly (umxaajydef ) View more	Positive	05 Nov 2025
ACR2025	Not Applicable	Giant Cell Arteritis	471	Tocilizumab	wgqwpeguvo(taqpnvvrqy) = kglqwhgjkj usgptnfouh (bfgsyeooek ) View more	Positive	24 Oct 2025
ACR2025	Not Applicable	Cardiovascular Diseases	206	Anakinra	xiwjurrccf(clauexjenb) = fhtfvamnzd weiaotvjab (ttahveksxm ) View more	Positive	24 Oct 2025
				Tocilizumab	vcqfqakffq(caegkqiqfr) = fjkrypetwi wugowqgrau (jlmhgiovgc )
ACR2025	Not Applicable	Giant Cell Arteritis	869	Tocilizumab	vsahkvolap(yldjqxwvze) = Safety outcomes of targeted drugs were similar with placebo in all of the involved studies. qudmtlfatc (tlwzwompyo )	Positive	24 Oct 2025
				Secukinumab

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