A Single-Center, Prospective Study Evaluating the Efficacy and Safety of Glofitamab Combined With CAR-T Therapy in Patients With High-Risk Relapsed/Refractory Large B-Cell Lymphoma

This study is a single-center, open-label, prospective study aimed at evaluating the efficacy and safety of Glofitamab combined with CAR-T therapy in patients with high-risk relapsed/refractory large B-cell lymphoma.

Start Date01 Mar 2026

Sponsor / Collaborator

Ruijin Hospital

NCT07198464

/ Not yet recruitingNot ApplicableIIT

A Prospective, Multicenter Clinical Study of Relmacabtagene Autoleucel Combined With Autologous Hematopoietic Stem Cell Transplantation, Orelabrutinib, and Sintilimab for Primary Central Nervous System Lymphoma

To evaluate the efficacy and safety of relmacabtagene autoleucel combined with autologous hematopoietic stem cell transplantation, orelabrutinib, and sintilimab as first-line or relapsed/refractory treatment for primary central nervous system diffuse large B-cell lymphoma.

Start Date07 Oct 2025

Sponsor / Collaborator

Zhengzhou University

NCT07077512

/ RecruitingPhase 2IIT

A Single-arm, Phase II Clinical Study of Relmacabtagene Autoleucel Combined With Sintilimab for Relapsed/Refractory B-cell Lymphoma.

This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of Relmacabtagene Autoleucel in combination with the Sintilimab regimen for the treatment of relapsed/refractory B-cell lymphoma

Start Date15 Sep 2025

Sponsor / Collaborator

Sun Yat-Sen University

100 Clinical Results associated with Relmacabtagene autoleucel

100 Translational Medicine associated with Relmacabtagene autoleucel

100 Patents (Medical) associated with Relmacabtagene autoleucel

Literatures (Medical) associated with Relmacabtagene autoleucel

24 Feb 2026·Blood Advances

Phase 2 study of relmacabtagene autoleucel (CD19 CAR-T) for relapsed/refractory mantle cell lymphoma in Chinese adults

Article

Author: Xia, Zhen ; Jin, Zheng-Ming ; Yang, Hai-Yan ; Xie, Yan ; Tian, Zhao-Zhao ; Zou, De-hui ; Zhou, Ke-Shu ; Cao, Jun-Ning ; He, Peng-Cheng ; Zang, Yi-Bei ; Huang, Hui-Qiang ; Li, Wen-Yu ; Gu, Yong-En ; Jing, Hong-Mei ; Li, Lan-Fang ; Zhu, Jun ; Jin, Jie ; Liang, Ai-Bin ; Zhou, Zi-Song ; Chen, Tong ; Mei, Heng ; Song, Yu-Qin

Abstract:

Relmacabtagene autoleucel (relma-cel), an anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, is approved in China for relapsed/refractory (R/R) large B-cell lymphoma and follicular lymphoma. This phase 2, open-label, single-arm, multicenter study evaluated its efficacy and safety in Chinese patients with heavily pretreated R/R mantle cell lymphoma (MCL). A total of 70 patients with R/R MCL who had received 1 to 9 previous therapies (including anthracycline or bendamustine chemotherapy, anti-CD20 antibodies, and Bruton tyrosine kinase [BTK] inhibitors) were enrolled. Of these, 59 received a single infusion of 100 × 106 CAR-positive T cells following leukapheresis. The primary end point was the objective response rate (ORR) at 3 months after infusion, assessed using the Lugano 2014 criteria. Secondary end points included the duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety. At 3 months, the ORR was 71.19% (95% confidence interval [CI], 57.92-82.24) with a complete response rate of 59.32% (95% CI, 45.75-71.93). After a median follow-up of 13.3 months (95% CI, 9.04-18.69), the median DOR was 18.1 months, PFS was 15.5 months, and OS was 19.5 months. Grade 3 or higher treatment-emergent adverse events were common, including neutropenia (76.3%), leukopenia (69.5%), and lymphopenia (47.5%). Severe cytokine release syndrome and neurotoxicity occurred in 6.8% of patients each, and all cases resolved fully. No fatal events were reported. These findings demonstrate that relma-cel offers high response rates, durable remissions, and manageable safety in Chinese patients with R/R MCL. This trial was registered at www.clinicaltrials.gov as #NCT04718883.

01 Dec 2025·JOURNAL OF AUTOIMMUNITY

Preliminary safety and efficacy of relmacabtagene autoleucel (relma-cel) in adults with moderately to severely active systemic lupus erythematosus: a phase I dose-escalation study

Article

Author: Xie, Cuiwei ; Zhang, Chunyan ; Xia, Peng ; Wang, Yiyang ; Yu, Ye ; Yang, Shaoying ; Lu, Liangjing

BACKGROUND:

Chimeric antigen receptor (CAR)-T cell therapy has emerged as a transformative treatment in autoimmune diseases. Relmacabtagene autoleucel (relma-cel) is an autologous, CD19-directed CAR-T cell product developed with a commercial-ready process in China. This study evaluates the safety and efficacy of relma-cel in patients with moderately to severely active systemic lupus erythematosus (SLE).

METHODS:

In this phase I, single-arm, dose escalation study, 8 female patients with moderately to severely active SLE were enrolled. All patients received a single infusion of relma-cel at escalating doses (50 × 10⁶, 75 × 10⁶, or 100 × 10⁶ CAR-T cells) after preconditioning with fludarabine and cyclophosphamide. The primary endpoints included the incidence of dose-limiting toxicities (DLTs), adverse events (AEs), and serious adverse events (SAEs). Secondary endpoints comprised pharmacokinetics, pharmacodynamics, and efficacy, which was evaluated by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), SLE Responder Index (SRI)-4, Lupus Low Disease Activity State (LLDAS), and Definition of Remission in SLE (DORIS) remission criteria.

RESULTS:

No dose-limiting toxicities were reported. Adverse events were manageable, with cytokine release syndrome (CRS) occurred in 7 patients and immune effector cell-associated neurotoxicity syndrome (ICANS) in 1 patient. The mean SLEDAI-2K score of patients decreased from 12.625 at baseline to 3.25 at follow-up. All patients achieved an SRI-4 response at 6 months, with 6 patients meeting LLDAS criteria and 5 achieving DORIS remission. Improvements in renal function and complement levels were also noted.

CONCLUSIONS:

Relma-cel demonstrates a manageable safety profile and promising efficacy in patients with moderately to severely active SLE. A dose of 100 × 10⁶ CAR-T cells was identified as the recommended phase II dose based on clinical response and tolerability.

01 Dec 2025·IMMUNITY

Eomesodermin+ CD4+ T cells are critical for curative immunotherapy outcomes

Article

Author: Erden Atilla ; Simone A. Minnie ; Geoffrey R. Hill ; Scott N. Furlan ; Tanvi Joshi ; Samuel R.W. Legg ; Ping Zhang ; Olivia G. Waltner ; Nicole S. Nemychenkov ; Françoise Haeseleer ; Alexandre V. Hirayama ; Shruti S. Bhise ; Jordan Gauthier ; Andrew D. Clouston ; Tomoko Sekiguchi ; Kokoro Abe ; Emily C. Liang ; Rachael C. Adams ; Kate H. Gartlan ; Motoko Koyama ; Ethan L. Nelson ; Albert C. Yeh ; Kathleen S. Ensbey

Interleukin 10 (IL-10)-producing CD4⁺ type-1 regulatory T cells (Tr1) promote immune tolerance during chronic infection, autoimmunity, and transplantation. However, specific Eomesodermin (Eomes)-dependent stages of Tr1 differentiation and function remain unclear. Using preclinical models of bone marrow transplantation (BMT), we demonstrated a Tr1 differentiation trajectory in vivo from Eomes⁺IL-10^- to Eomes⁺IL-10⁺ subsets with the acquisition of cytokine, cytolytic, and exhaustion features. The Eomes⁺CD4⁺ fraction represented the dominant cytotoxic subset after BMT, mediating graft-versus-leukemia effects while limiting inflammation. In CD19-targeted chimeric antigen receptor (CAR) T cell immunotherapy, Eomes drove the same CD4⁺ Tr1 phenotype that controlled cytolysis, while mitigating immune toxicity and promoting persistence. In individuals with high-grade B cell lymphomas that had long-term disease control after receiving commercial CD19-targeted CAR T cells, Eomes⁺ Tr1 cells represented a stable population comprising 40%-80% of the CD4⁺ CAR T cell population. Hence, Eomes controls both regulatory and cytotoxic programs in CD4⁺ T cells, essential for curative immunotherapy outcomes.

News (Medical) associated with Relmacabtagene autoleucel

04 Feb 2026

·www.prnewswire.com

Oncolytic Virus Clinical Trial Landscape Gains Momentum: 100+ Companies Lead the Charge in Pioneering New Treatments | DelveInsight

The oncolytic virus therapy landscape has expanded steadily over the past decade, with over 100 companies worldwide pursuing clinical or preclinical programs. A few leaders, such as Candel Therapeutics, Binhui Biopharmaceutical, Oncolytics Biotech, EpicentRx, Hangzhou Converd, and others, anchor the mid and late-stage pipeline. LAS VEGAS, Feb. 4, 2026 /PRNewswire/ -- DelveInsight's Oncolytic Virus Competitive Landscape 2026 report provides comprehensive global coverage of pipeline oncolytic virus therapies across various stages of clinical development. The report offers an in-depth analysis of key trends, emerging therapies, and the competitive landscape, highlighting the strategies of major pharmaceutical companies to advance their pipelines and capitalize on future growth opportunities. In addition, it provides critical insights into clinical trial benchmarking, partnering and licensing, and regulatory pathways with the FDA and EMA, enabling stakeholders to make informed decisions and optimize development strategies in the oncolytic virus domain. Oncolytic Virus Clinical Trial Analysis Summary DelveInsight's oncolytic virus pipeline report highlights a robust landscape, with 100+ active players developing 110+ oncolytic virus drugs. Key oncolytic virus companies such as Oncolytics Biotech, SillaJen, Candel Therapeutics, Binhui Biopharmaceutical, Oryx GmbH, Oncolys Biopharma, EpicentRx, Theriva Biologics, Lokon Pharma, DNAtrix, Surv BioPharma Inc., Treovir, Immvira Pharma, Virogin Biotech, OrienGene Biotechnology, Apices Soluciones, Vyriad, Transgene, BioEclipse Therapeutics, Imugene, CG Oncology, Istari Oncology, Akamis Bio, Elicera Therapeutics, and others are evaluating new oncolytic virus drugs to improve the treatment landscape. Promising pipeline oncolytic virus therapies, such as Pelareorep, Pexa-Vec, CAN-2409, BS001, ParvOryx, Telomelysin, AdAPT-001, VCN-01, LOAd 703, DNX-2401, Surv.m-CRA-1, G207, MVR-T3011, VG161, OrienX010, AloCelyvir, Voyager-V1, TG6002, CRX-100, CF33-hNIS, CG0070, PVS-RIPO, NG-350A, ELC-201, and others, are in different phases of oncolytic virus clinical trials. Request a sample and discover the recent advances in oncolytic virus drugs @ Key Factors Driving the Oncolytic Virus Therapy Market Growing Cancer Incidence: The global rise in cancer prevalence, especially in hard-to-treat solid tumors, has intensified demand for novel, effective treatment modalities. Conventional therapies such as chemotherapy and radiation often have significant side effects and limited long-term efficacy, motivating the adoption of immunotherapeutic alternatives like oncolytic virus therapies. Increasing Understanding of Cancer Biology: Growing knowledge of cancer biology has enabled the development of oncolytic virus therapies that selectively target and destroy cancer cells while sparing healthy cells. Advancements in Viral Engineering: These advances are enabling more precise, targeted oncolytic virus therapies, significantly expanding the global oncolytic virus therapy market. Rising Adoption of Personalized Medicine: Oncolytic virus therapies align closely with personalized treatment approaches by enabling tailored viral constructs and immunomodulatory payloads based on tumor genomics. What is Oncolytic Virus Therapy? Oncolytic virus therapy is an innovative form of cancer treatment that uses genetically engineered or naturally occurring viruses to selectively infect and destroy cancer cells. These viruses replicate inside tumor cells, causing them to burst while leaving healthy cells largely unharmed. As the cancer cells break apart, they release tumor antigens that help activate the body's immune system, enhancing its ability to recognize and attack remaining cancer cells. This dual action, direct tumor destruction and immune stimulation, makes oncolytic virus therapy a promising approach in modern oncology, often used alongside other treatments such as immunotherapy or chemotherapy. Applications of Oncolytic Virus Therapy Oncolytic virus (OV) cancer therapies can be used for both diagnosis and treatment of cancer. OVs can function as cancer vaccines by boosting tumor-specific T-cell responses. Oncolytic viruses can be engineered with immunostimulatory molecules to enhance immune activation. OVs show strong synergy when combined with other immunotherapies, such as checkpoint inhibitors. Oncolytic Viruses in Combination with Chemotherapy Chemotherapy works systemically, unlike surgical resection or radiotherapy. It remains essential for treating patients with disseminated (widespread) cancer. Because chemotherapy is systemic, it is often combined with oncolytic viruses (OVs), which typically require localized delivery to achieve a strong antitumor effect. Systemically administered OVs have shown limited therapeutic benefit in several clinical trials. Delivering OVs effectively to metastatic sites remains a major challenge. Therefore, using chemotherapy as a systemic adjuvant to localized OV therapy is of significant clinical interest and is currently being actively investigated. Oncolytic Virus Market Analysis: Drug Profile IMLYGIC: Amgen IMLYGIC (talimogene laherparepvec), developed by Amgen, is a first-of-its-kind oncolytic viral therapy for melanoma that cannot be surgically removed. It combines direct tumors destruction with immune system stimulation. The therapy is based on a genetically engineered herpesvirus engineered to preferentially infect and destroy cancer cells, releasing GM-CSF to trigger a broader anti-tumor immune response. In the Phase III OPTiM trial, IMLYGIC produced durable responses in about 16% of patients, compared with 2% with GM-CSF alone, and overall responses in roughly 26%. Patients at earlier disease stages achieved better outcomes, with some achieving long-term control. The treatment is usually well tolerated, with most adverse effects being mild and resembling flu symptoms. Although its independent effect on survival and deep organ metastases is modest, its value is most evident when combined with checkpoint inhibitors. Early data show response rates approaching 56%, and ongoing studies aim to further define these synergistic benefits. As the first FDA-approved oncolytic virus in the West, IMLYGIC has validated the broader concept of viral immunotherapy and is now being explored as a component of combination immuno-oncology approaches. Oncorine: Shanghai Sunway Biotech Oncorine, also known as H101, is a genetically engineered adenovirus with an E1B gene deletion developed by Shanghai Sunway Biotech in China. It is administered alongside chemotherapy to treat nasopharyngeal carcinoma and head and neck cancers. Its approval and effective clinical use have significantly advanced oncolytic virus–based cancer immunotherapy. Marketed as Recombinant Human Adenovirus Type 5 Injection, Oncorine became the first oncolytic virus approved for cancer treatment by the Chinese State Food and Drug Administration (CFDA) in November 2005. Since its introduction, it has demonstrated a favorable safety profile and notable antitumor activity across various cancers and malignant pleural effusions. Exploratory clinical studies have also evaluated Oncorine for treating liver cancers, pancreatic cancer, cervical cancer, malignant melanoma, and metastatic liver tumors. Find out more about oncolytic virus cancer drugs @ Oncolytic Virus Analysis A snapshot of the Pipeline Oncolytic Virus Drugs mentioned in the report: Learn more about the emerging oncolytic virus therapies @ Oncolytic Virus Clinical Trials Recent Developments in Oncolytic Virus Treatment Space In November 2025, Imugene Ltd and JW Therapeutics announced a co-development collaboration to evaluate the combination of Imugene's oncolytic virus CF33-CD19 (onCARlytics) and JW's Carteyva®, a CD19-directed autologous CAR-T cell therapy, for patients with advanced solid tumors. This collaboration includes preclinical in vitro and in vivo studies, followed by a Phase I investigator-initiated trial to be conducted exclusively in China at premier CAR-T clinical centers. The approach utilizes Imugene's CF33-CD19 virus to induce CD19 expression on tumor cells, rendering them susceptible to targeting by CD19 CAR-T therapies, a transformative "mark and kill" strategy. In July 2025, Calidi Biotherapeutics, Inc., a clinical-stage biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease, announced that it received Fast Track designation from the U.S. Food and Drug Administration (FDA) for CLD-201 (SuperNova), the company's allogeneic adipose stem-cell loaded oncolytic virus for the treatment of soft tissue sarcoma. In June 2025, Oncolytics Biotech presented a poster demonstrating the role of pelareorep in activating anti-tumor immunity in PDAC. In May 2025, Candel Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) had granted Regenerative Medicine Advanced Therapy (RMAT) designation to CAN-2409 (aglatimagene besadenovec), the Company's biological immunotherapy lead candidate, for the treatment of newly diagnosed localized prostate cancer in patients with intermediate-to-high-risk disease. CAN-2409 was also previously granted FDA Fast Track designation for the same indication. In May 2025, Elicera Therapeutics AB announced that it had entered into a Material Transfer Agreement (MTA) with University Hospital Tübingen in Germany. Under the agreement, the company's oncolytic virus candidates ELC-100 and ELC-201 will be included in tests aimed at developing a new type of companion diagnostic to predict the potential success of a novel neuroendocrine neoplasm (NEN) therapy, immuno-virotherapy. In April 2025, Hangzhou ConVerd Co., Ltd. announced that the first Phase IIa clinical study of hV01, ConVerd's first oncolytic vaccinia virus product, had successfully completed first patient dosing, with the subject in good condition. This phase IIa clinical study investigates the administration of a single dose of recombinant human IL-21 oncolytic poxvirus injection (hV01) per cycle for the treatment of patients diagnosed with advanced sarcoma and cervical cancer. It is important to note that the indication is for advanced sarcoma and recurrent or metastatic cervical cancer for which there is no standard of care available at this stage of the treatment process, or where standard of care has failed. Scope of the Oncolytic Virus Pipeline Report Coverage: Global Key Oncolytic Virus Companies: Oncolytics Biotech, SillaJen, Candel Therapeutics, Binhui Biopharmaceutical, Oryx GmbH, Oncolys Biopharma, EpicentRx, Theriva Biologics, Lokon Pharma, DNAtrix, Surv BioPharma Inc., Treovir, Immvira Pharma, Virogin Biotech, OrienGene Biotechnology, Apices Soluciones, Vyriad, Transgene, BioEclipse Therapeutics, Imugene, CG Oncology, Istari Oncology, Akamis Bio, Elicera Therapeutics, and others Key Oncolytic Virus Pipeline Therapies: Pelareorep, Pexa-Vec, CAN-2409, BS001, ParvOryx, Telomelysin, AdAPT-001, VCN-01, LOAd 703, DNX-2401, Surv.m-CRA-1, G207, MVR-T3011, VG161, OrienX010, AloCelyvir, Voyager-V1, TG6002, CRX-100, CF33-hNIS, CG0070, PVS-RIPO, NG-350A, ELC-201, and others Dive deep into rich insights for new oncolytic Virus treatments, visit @ Oncolytic Virus Drugs Table of Contents Related Reports Oncolytic Virus Therapies Market Oncolytic Virus Therapies Market Size, Target Population, Competitive Landscape, and Market Forecast – 2034 report deliver an in-depth understanding of the market trends, market drivers, market barriers, and key oncolytic virus therapies companies including Targovax, Genelux, Imugene, EpicentRx, Replimune, Genelux Corporation, Candel Therapeutics, DNAtrix, SillaJen, Treovir, Lokon Pharma AB, Istari Oncology, CG Oncology, Amgen, Daiichi Sankyo, and others. Melanoma Market Melanoma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key melanoma companies including IO Biotech, Merck Sharp & Dohme, Eisai, Regeneron Pharmaceuticals, Iovance Biotherapeutics, Highlight Therapeutics, Linnaeus Therapeutics, Spring Bank Pharmaceuticals, Taiga Biotechnologies, Inc., Aivita Biomedical, Inc., Genentech, Inc., Dana-Farber Cancer Institute, BioMed Valley Discoveries, Inc, Amgen, Checkmate Pharmaceuticals, Astellas Pharma Inc, Galectin Therapeutics Inc., Eucure (Beijing) Biopharma Co., Ltd, Mologen AG, Ultimovacs ASA, Seagen Inc., MedImmune LLC, OnKure, Inc., Syntrix Biosystems, Inc., Anaveon AG, iOx Therapeutics, Portage Biotech, ModernaTX, Inc., Nektar Therapeutics, BioNTech SE, Sapience Therapeutics, HUYABIO International, LLC., Provectus Biopharmaceuticals, Inc., Cantargia AB, Turnstone Biologics, Corp., Aura Biosciences, F-star Therapeutics, Inc., Day One Biopharmaceuticals, Inc., Kinnate Biopharma, Xencor, Inc., HiFiBiO Therapeutics, and others. Colorectal Cancer Market Colorectal Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key colorectal cancer companies, including Mirati Therapeutics, Exelixis, Enterome, Arcus Biosciences, Lyell Immunopharma, AstraZeneca, Novartis Pharmaceuticals, Surgimab, Numab Therapeutics, SOTIO Biotech, Amgen, Sichuan Baili Pharmaceutical, Qilu Pharmaceutical, Bristol-Myers Squibb, NGM Biopharmaceuticals, Takeda, PureTech, Pfizer, Kezar Life Sciences, Salubris, Biotherapeutics , and others. Pancreatic Cancer Market Pancreatic Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key pancreatic cancer companies including FibroGen, OSE Immunotherapeutics, Lokon Pharma, Oncotelic Inc., Tesaro, Inc., Helix BioPharma Corporation, Theradex, Tvardi Therapeutics, Incorporated, AIM ImmunoTech Inc., BioNTech SE, Prestige Biopharma Limited, HCW Biologics, Cantex Pharmaceuticals, XBiotech, Inc., Lumicell, Inc., CARsgen Therapeutics Co., Ltd., Panbela Therapeutics, Inc. , and others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP 21% more press release views with Request a Demo

Clinical ResultPhase 2ImmunotherapyFast TrackPhase 3

28 Nov 2025

·www.prnewswire.com

Imugene and JW Therapeutics Announce a Collaboration to Advance onCARlytics and Carteyva® Combination in Solid Tumours

Imugene and JW Therapeutics (Shanghai) Co., LTD have entered a strategic collaboration to evaluate a novel combination therapy using Imugene's onCARlytics (CF33-CD19) oncolytic virus and JW's CD19 CAR-T cell therapy, Carteyva®, in refractory solid tumors. The collaboration includes preclinical studies, followed by a Phase 1 investigator-initiated trial (IIT) in China targeting difficult-to-treat cancers. This approach represents a first-in-class "mark and kill" strategy, leveraging oncolytic virus-induced CD19 expression to make solid tumors targetable by CD19-CAR T cells. The collaboration leverages JW's commercial CAR-T infrastructure and Imugene's clinical onCARlytics platform to generate preclinical and clinical data and inform further clinical development. SYDNEY and SHANGHAI, Nov. 27, 2025 /PRNewswire/ -- Imugene Ltd (ASX:IMU), a clinical-stage immuno-oncology company, and JW Therapeutics (Shanghai) Co., LTD (HKEX:2126), a leading biotechnology company focused on cell-based immunotherapies, today announced a co-development collaboration to evaluate the combination of Imugene's oncolytic virus CF33-CD19 (onCARlytics) and JW's Carteyva®—a CD19-directed autologous CAR-T cell therapy—for patients with advanced solid tumors. This collaboration includes preclinical in vitro and in vivo studies, followed by a Phase 1 investigator-initiated trial to be conducted exclusively in China at premier CAR-T clinical centers. The approach utilizes Imugene's CF33-CD19 virus to induce CD19 expression on tumor cells, rendering them susceptible to targeting by CD19 CAR-T therapies—a transformative "mark and kill" strategy. "This collaboration allows us to validate our onCARlytics platform in combination with an approved autologous CAR-T product," said Leslie Chong, Managing Director and CEO of Imugene. "We believe Carteyva® which is already approved in blood cancer is an ideal choice, and this initiative enables us to generate impactful data efficiently while exploring a breakthrough treatment paradigm for solid tumours." With clear go/no-go decision points, and milestones, the collaboration ensures disciplined capital allocation while enabling strategic flexibility. For more information please contact: Leslie Chong Managing Director and Chief Executive Officer [email protected] Investor Enquiries [email protected] Media Enquiries [email protected] Connect with us on LinkedIn @Imugene Limited Follow us on Twitter @TeamImugene Watch us on YouTube @ImugeneLimited About Imugene (ASX:IMU) Imugene is a clinical stage immuno-oncology company developing a range of new and novel immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate tumours. Our unique platform technologies seek to harness the body's immune system against tumours, potentially achieving a similar or greater effect than synthetically manufactured monoclonal antibody and other immunotherapies. Our pipeline includes an off-the-shelf (allogeneic) cell therapy CAR T drug azer-cel (azercabtagene zapreleucel) which targets CD19 to treat blood cancers. Our pipeline also includes oncolytic virotherapy (CF33) aimed at treating a variety of cancers in combination with standard of care drugs and emerging immunotherapies such as CAR T's for solid tumours. We are supported by a leading team of international cancer experts with extensive experience in developing novel cancer therapies that are currently marketed globally. Our vision is to help transform and improve the treatment of cancer and the lives of the millions of patients who need effective treatments. This vision is backed by a growing body of clinical evidence and peer-reviewed research. Together with leading specialists and medical professionals, we believe Imugene's immuno-oncology therapies may become foundation treatments for cancer. Our goal is to ensure that Imugene and its shareholders are at the forefront of this rapidly growing global market.  About JW Therapeutics (HKEX: 2126) JW Therapeutics (HKEx:2126) is an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products. Since its founding in 2016, JW Therapeutics has built an integrated platform for product development in cell immunotherapy, as well as a product pipeline covering hematologic malignancies, solid tumors and autoimmune diseases. JW Therapeutics is committed to bringing breakthrough and quality cell immunotherapy products and the hope of a cure to patients in China and beyond, and to leading the healthy and standardized development of China's cell immunotherapy industry. For more information, please visit . Daniel Tu VP, Head of Corporate Strategy, Business Development & Alliance [email protected] Release authorised by the Managing Director and Chief Executive Officer Imugene Limited and Chief Executive Officer JW Therapeutics. SOURCE Imugene Ltd 21% more press release views with Request a Demo

ImmunotherapyPhase 1Cell Therapy

10 Jan 2025

·www.prnewswire.com

JW Therapeutics Announces Receipt of Breakthrough Therapy Designation for Carteyva® in China as Second-line Treatment in Relapsed or Refractory adult Large B-cell Lymphoma

SHANGHAI, Jan. 10, 2025 /PRNewswire/ -- JW Therapeutics (HKEx: 2126), an independent and innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China (NMPA) granted Breakthrough Therapy Designation for Carteyva® (relmacabtagene autoleucel injection) as second-line treatment in adults with relapsed or refractory large B-cell lymphoma (r/r LBCL) . Carteyva® is an anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product independently developed by JW Therapeutics. Continue Reading The Breakthrough Therapy Designation was supported by the results from the clinical study aimed to assess the efficacy and safety of Carteyva® in Chinese adults with r/r LBCL who were not intended for autologous stem cell transplantation after failure of first-line therapy. This is the first clinical result obtained in Chinese patients. Large B-cell lymphoma is a highly aggressive non-Hodgkin's lymphoma and is the most common subtype of lymphoma in adults. LBCL is a potentially curable disease, but 30-40% of patients still experience refractory or relapse1. Patients who fail first-line treatment have a poor outcome, and although conventional treatment options such as high-dose chemotherapy followed by autologous haematopoietic stem cell transplantation (HDCT/ASCT) are the standard of care, approximately more than half of the patients are not suitable for ASCT due to a variety of reasons such as advanced age, comorbidities, and so on, and there is no standard of care with a very poor outcome2. There are still urgent unmet medical needs to develop additional active therapeutic approaches for the treatment of r/r LBCL. About Relmacabtagene Autoleucel Injection Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name for oncology indications: Carteyva®) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). Being the first product of JW Therapeutics, Carteyva® has been approved by NMPA for three indications, including the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy, the treatment of adult patients with follicular lymphoma that is refractory or that relapses within 24 months of second-line or above systemic treatment (r/r FL), and the treatment of adult patients with relapsed or refractory mantle cell lymphoma (r/r MCL) after two or more lines of systemic therapy including bruton tyrosine kinase inhibitors (BTKi), making it the first CAR-T product approved as a Category 1 biologics product in China. Currently, it is the only CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, priority review and breakthrough therapy designations. About JWCAR029-216 Study (NCT06093841) This is a phase II, open-label, single-arm, multicenter study which aims to assess the efficacy and safety of Carteyva® in Chinese adults with r/r LBCL who were not intended for autologous stem cell transplantation after failure of first-line therapy. This is the first clinical study to evaluate such novel therapy in Chinese LBCL patients. The study will be conformance with the Chinese clinical practices and will truly reveal the efficacy and safety data in Chinese patients. The study is currently ongoing. Preliminary clinical data found Carteyva® providing outstanding efficacy and good safety profile for r/r LBCL patients, with a best overall response rate of 84%. About JW Therapeutics JW Therapeutics (HKEx:2126) is an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products. Since its founding in 2016, JW Therapeutics has built an integrated platform for product development in cell immunotherapy, as well as a product pipeline covering hematologic malignancies, solid tumors and autoimmune diseases. JW Therapeutics is committed to bringing breakthrough and quality cell immunotherapy products and the hope of a cure to patients in China and beyond, and to leading the healthy and standardized development of China's cell immunotherapy industry. For more information, please visit . Forward-Looking Statements The forward-looking statements are based on the management's expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described. Significant risks and uncertainties, include those discussed below and more fully described in Hong Kong Exchanges and Clearing Limited (HKEx) reports filed by the Company. Unless otherwise noted, the Company is providing this information as of the date it publicized, and expressly disclaims any duty to update information contained in the issues and relevant information, or provide any explanation. For detailed information, please visit the company website: . SOURCE JW Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyPhase 2Drug ApprovalBreakthrough TherapyCell Therapy

100 Deals associated with Relmacabtagene autoleucel

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Recurrent Follicular Lymphoma	Macao	JW Therapeutics (Shanghai) Co., Ltd.	04 Jun 2025
Refractory Follicular Lymphoma	Macao	JW Therapeutics (Shanghai) Co., Ltd.	04 Jun 2025
Mantle cell lymphoma recurrent	China	JW Therapeutics (Shanghai) Co., Ltd.	20 Aug 2024
Mantle cell lymphoma refractory	China	JW Therapeutics (Shanghai) Co., Ltd.	20 Aug 2024
Follicular Lymphoma	China	JW Therapeutics (Shanghai) Co., Ltd.	30 Sep 2022
Diffuse Large B-Cell Lymphoma	China	JW Therapeutics (Shanghai) Co., Ltd.	01 Sep 2021
Large B-cell lymphoma	China	JW Therapeutics (Shanghai) Co., Ltd.	01 Sep 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Aggressive B-Cell Non-Hodgkin Lymphoma	NDA/BLA	China	JW Therapeutics (Suzhou) Co., Ltd.	24 May 2025
Aggressive B-Cell Non-Hodgkin Lymphoma	NDA/BLA	China	JW Therapeutics (Shanghai) Co., Ltd.	24 May 2025
High grade B-cell lymphoma	Phase 3	China	JW Therapeutics (Shanghai) Co., Ltd.	08 Jul 2022
Marginal Zone B-Cell Lymphoma	Phase 3	China	JW Therapeutics (Shanghai) Co., Ltd.	08 Jul 2022
Primary mediastinal large B-cell lymphoma recurrent	Phase 3	China	JW Therapeutics (Shanghai) Co., Ltd.	08 Jul 2022
Systemic Lupus Erythematosus	Phase 2	China	JW Therapeutics (Shanghai) Co., Ltd.	25 Dec 2023
Primary Central Nervous System Lymphoma	Phase 2	China	Ruijin Hospital	30 Nov 2023
Indolent B-Cell Non-Hodgkin Lymphoma	Phase 2	China	JW Therapeutics (Shanghai) Co., Ltd.	03 Nov 2023
Mediastinal large B-cell lymphoma	Phase 2	China	Shanghai Ming Ju Biotechnology Co. Ltd.	11 Jun 2019
Scleroderma, Diffuse	Phase 1	China	Shanghai Ming Ju Biotechnology Co. Ltd.	12 Jun 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Corporate Publications \| Company_Website Manual	Phase 2	Lymphoma	-	Relmacabtagene Autoleucel	bkgytrmpls(eytllrgllv) = gpptwpcfdi ueykyliugj (yqzrinvhtl ) View more	Positive	09 Oct 2025
NCT04718883 (Blood Adv) Manual	Phase 2	Mantle cell lymphoma refractory	70	Relma-cel	vmzowppepy(wqxjajbyhx) = fbojcekhsx ajbvxrnyqq (ipczcgqwun, 57.92 - 82.24) View more	Positive	14 Aug 2025
PF918 (EHA2025)	Phase 2	Aggressive B-Cell Non-Hodgkin Lymphoma Second line CD19	53	Relma-cel	qvgmhekryd(hxhjegfxqw) = qkqfjmfpdf oufqdzraoy (kxfyrsexhx, 67.4 - 91.1) View more	Positive	14 May 2025
PF918 (EHA2025)	Phase 2	Aggressive B-Cell Non-Hodgkin Lymphoma Second line CD19	53	RELMACABTAGENE AUTOLEUCEL (Historical control group)	txpxdjhghp(dckbfxxarl) = ovtlbvpiym yitfayoksb (aldobzaike )	Positive	14 May 2025
NCT05765006 (Pubmed \| EClinicalMedicine) Manual	Phase 1	Systemic Lupus Erythematosus	8	Relmacabtagene autoleucel	amzrqnqueo(ltcsdxkryj) = qbzoznwhcf qnxtlnfmii (inylajmsrd ) View more	Positive	01 May 2025
NCT05765006 (EULAR 12024 \| EULAR 22024) Manual	Phase 1	Systemic Lupus Erythematosus	3	RELMACABTAGENE AUTOLEUCEL	yzarafjfay(kzevdyyhyn) = pxjyzljtjy jbnjjowclf (esqcyxfdbc ) View more	Positive	12 Jun 2024
NCT04089215 (RELIANCE, ASCO2024) Manual	Phase 2	Large B-cell lymphoma Last line \| Third line CD19	58	relma-cel 100 × 106 CAR+ T cells	oaugwisows(qnmzqhuakt) = zpvvaabarv eebhgrotfd (pupvgsrloz ) View more	Positive	24 May 2024
NCT04089215 (RELIANCE, ASCO2024) Manual	Phase 2	Large B-cell lymphoma Last line \| Third line CD19	58	relma-cel 150 × 106 CAR+ T cells	oaugwisows(qnmzqhuakt) = jgxykpngsv eebhgrotfd (pupvgsrloz ) View more	Positive	24 May 2024
NCT05727683 (EHA 12024 \| EHA 22024) Manual	Phase 1	Precursor B-Cell Lymphoblastic Leukemia-Lymphoma	6	Relma-cel	raqqedklcn(ohczqhfklm) = The most common TEAE were cytopenias (6/6) and CRS (6/6). with none of ≥ grade 3 CRS. 2 patients experienced neurotoxicity (NT), with 1 of grade 4 NT. bngyiturae (vautpdsmbp ) View more	Negative	14 May 2024
NCT04089215 (RELIANCE study, EHA2024)	Phase 2	Refractory Central Nervous System Lymphoma CD19	22	commercial relmacabtagene autoleucel (relma-cel) (Relma-cel)	hksrbsvmqi(fscpykrwmb) = idktxmcwim szrnucvvwj (uwydyytlcm ) View more	Positive	14 May 2024
PRNewswire Manual	Not Applicable	Mantle-Cell Lymphoma	59	Carteyva	xfwfeqmslm(pzralmqxrr) = krkoupiskg nputzpyeoz (yfoxpdfzng ) View more	Positive	04 Jan 2024
NCT04718883 (ASH2023) Manual	Phase 2	Mantle-Cell Lymphoma	56	Relmacabtagene Autoleucel	ydyhndawcz(gzbzzwptze) = ishrtkfifd wpksxstboo (qwmwechlio ) View more	Positive	10 Dec 2023

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