RegulationOrphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Orphan Drug (Japan), Orphan Drug (South Korea), Conditional marketing approval (European Union), Breakthrough Therapy (China), Priority Review (United States), Orphan Drug (United Kingdom), Conditional marketing approval (China), Special Review Project (China), Priority Review (China), Breakthrough Therapy (United States)

Structure/Sequence

Sequence Code 13031374

Source: *****

Clinical Trials associated with Ciltacabtagene autoleucel

NCT07093554

/ RecruitingPhase 1IIT

Cilta-Talq Fusion Study: A Phase 1b Study of Talquetamab Bridging Therapy Followed by Ciltacabtagene Autoleucel in Patients With Relapsed/Refractory Multiple Myeloma

This is a single-arm, open-label, phase 1b study evaluating the safety and feasibility of using talquetamab as bridging therapy prior to cilta-cel in patients with relapsed and refractory multiple myeloma (RRMM).

Start Date02 Dec 2025

Sponsor / Collaborator

Medical College of Wisconsin

NCT07149857

/ RecruitingPhase 2

A Phase 2 Multicohort Trial to Further Characterize the Efficacy and Safety of Ciltacabtagene Autoleucel

The purpose of this study is to evaluate how well (efficacy) cilta-cel works when given with a fludarabine-free lymphodepletion regimen (a process of reducing the number of lymphocytes, a type of white blood cell in the body, typically through chemotherapy), or an alternative administration of cilta-cel infusion following a cyclophosphamide and fludarabine lymphodepletion regimen.

Start Date03 Oct 2025

Sponsor / Collaborator

Janssen Research & Development LLC

NCT06940297

/ RecruitingPhase 2IIT

DART: Phase II Study of Dasatinib and Quercetin in Patients With Relapsed, Refractory Multiple Myeloma Receiving CAR-T Therapy

This phase II trial tests how well giving dasatinib and quercetin with cyclophosphamide, fludarabine and chimeric antigen receptor (CAR)-T cell therapy works in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Dasatinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Quercetin is a compound found in plants that may prevent multiple myeloma from forming. Chemotherapy such as cyclophosphamide and fludarabine are given to help kill any remaining cancer cells in the body and to prepare the bone marrow for CAR-T therapy. Chimeric antigen receptor T-cell Therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving dasatinib and quercetin with cyclophosphamide, fludarabine and CAR-T cell therapy may kill more cancer cells in patients with relapsed or refractory multiple myeloma.

Start Date23 Jun 2025

Sponsor / Collaborator

Mayo Clinic

[+1]

100 Clinical Results associated with Ciltacabtagene autoleucel

100 Translational Medicine associated with Ciltacabtagene autoleucel

100 Patents (Medical) associated with Ciltacabtagene autoleucel

348

Literatures (Medical) associated with Ciltacabtagene autoleucel

01 Feb 2026·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Chimeric antigen receptor T-cell therapy and immune effector cell-associated neurotoxicity syndrome: A meta-analysis

Review

Author: Bunevicius, Adomas ; Munteh, Diana ; Mammi, Marco ; Mekary, Rania A ; Hundel, Jessie ; D'Amore, Fabio ; Donthineni, Karun ; Thirugnanam, Ashwini

BACKGROUND:

Chimeric antigen receptor (CAR) T-cell therapy, a form of adoptive immunotherapy, has expanded treatment options for various hematologic malignancies. However, CAR T therapy is associated with a range of side effects, including immune effector cell-associated neurotoxicity syndrome (ICANS), with variable incidence and severity.

OBJECTIVE:

To evaluate the incidence and characteristics of ICANS following CAR T therapy in different hematological diseases, with a focus on product-specific variations.

METHODS:

We searched PubMed, Embase, and Cochrane Library through 2/16/2024. Pooled incidence and 95 % confidence intervals (CIs) for ICANS (overall, more severe, and less severe) were estimated via a random-effects model. Separate meta-analyses were conducted for each lymphoma type - large B-cell lymphoma (LBCL), multiple myeloma (MM), and mantle cell lymphoma (MCL).

RESULTS:

Of 259 articles reviewed, 30 studies were meta-analyzed. Among LBCL patients, the incidence of ICANS appeared lower with tisagenlecleucel (16.5 %, 95 % CI: 12.9-20.9; n = 1108 patients) than with axicabtagene ciloleucel (45.6 %, 95 % CI: 39.6-51.7; n = 1579). In MM patients, the incidence appeared lower with ciltacabtagene autoleucel (10.4 %, 95 % CI: 5.2-19.9; n = 348) than with idecabtagene vicleucel (18.3 %; 95 % CI: 15.4-21.5; n = 631). For MCL patients (n = 198), brexucabtagene autoleucel showed a high overall incidence of ICANS (61.2 %; 95 % CI: 54.2-67.8), with more severe events (32.9 %; 95 % CI: 26.7 %-39.7 %) slightly exceeding less severe ones (28.6 %; 95 % CI: 22.7 %-35.3 %).

CONCLUSION:

Tisa-cel and cilta-cel showed a more favorable ICANS safety profile in LBCL and MM patients, respectively, while brexu-cel showed a higher ICANS incidence in MCL patients. Further comparative studies are needed to adjust for treatment-related confounders.

13 Jan 2026·Blood Advances

New comorbidity index associated with survival after chimeric antigen receptor T-cell therapy for large B-cell lymphoma

Article

Author: Kebriaei, Partow ; Hashmi, Hamza ; Beitinjaneh, Amer M. ; Strouse, Christopher ; Ahmed, Sairah ; Shouval, Roni ; Vallurupalli, Anusha ; Mussetti, Alberto ; Saber, Wael ; Hill, LaQuisa C. ; Kittai, Adam S. ; Locke, Frederick L. ; Moskop, Amy ; Geethakumari, Praveen Ramakrishnan ; Turtle, Cameron J. ; Kim, Soyoung ; Sorror, Mohamed ; Bar, Merav ; Ganguly, Siddhartha ; Perales, Miguel-Angel ; Mead, Elena ; Badar, Talha ; Pennisi, Martina ; Olson, Amanda L. ; Cashen, Amanda ; McGuirk, Joseph P. ; Shpall, Elizabeth J. ; Pasquini, Marcelo C. ; Magalhaes-Silverman, Margarida ; Lulla, Premal D. ; Farooq, Umar ; Wudhikarn, Kitsada ; Jain, Tania ; Riedell, Peter A. ; Barba, Pere ; Awan, Farrukh T. ; Greenbaum, Uri ; Hematti, Peiman ; Foglesong, Jessica ; Nishihori, Taiga ; Jain, Michael D. ; Elsawy, Mahmoud ; Oloyede, Temitope ; Dholaria, Bhagirathbhai ; Bachanova, Veronika

Abstract:

The cumulative impact of baseline comorbidities on outcomes of chimeric antigen receptor T-cell (CAR-T) therapy is not well established. Therefore, we developed and validated a Cellular Therapy Comorbidity Index (CT-CI) to predict outcomes following CD19-directed CAR-T therapy for large B-cell lymphoma (LBCL). Patients aged 18 or older receiving commercial CAR-T therapy for LBCL during 2017 to 2020 were selected from the Center for International Blood and Marrow Transplant Research registry. Patients were randomly assigned to training or validation cohorts. Comorbidities given weighted scores comprised the CT-CI, which was then validated for overall survival (OS) prognostication. A total of 1916 patients from 97 medical centers were included, with a median age of 64 years (19-91 years). About 70% of patients had comorbidities, such as cardiac disease (12%); diabetes (14%); hepatic dysfunction (mild, 8%; moderate to severe, 2%); psychiatric disturbance (18%); and pulmonary dysfunction (moderate, 15%; severe, 12%). The CT-CI was calculated, stratified patients in 3 categories, and was associated with increased mortality. Patients with higher CT-CI scores had worse OS (CT-CI 1: hazard ratio [HR], 1.37 [95% confidence interval [CI], 1.16-1.62; P< .001]; CT-CI 2: HR, 1.49 [95% CI, 1.17-1.89; P = .001]; CT-CI ≥ 3: HR, 2.55 [95% CI, 1.90-3.42; P< .001]). Higher CT-CI scores predicted treatment-related mortality and relapse. There was no correlation between the CT-CI score and CAR-T–related toxicities. The novel CT-CI score stratifies the effect of patient comorbidities on survival after CAR-T therapy and can be used for clinical decision-making and treatment selection in high-risk populations. However, comorbidities and fear of increased toxicity should not preclude patients from this effective therapy.

02 Jan 2026·Expert Opinion On Drug Safety

Neurotoxicity associated with chimeric antigen receptor T-cell therapy: a real-world study leveraging the FDA Adverse Event Reporting System

Article

Author: He, Jia ; Yuan, Lei ; Ye, Xiaofei ; Fang, Shihua ; Shi, Wentao ; Hu, Fangyuan ; Cao, Yang ; Liu, Shenglian ; Xu, Feng ; Zhai, Yinghong

BACKGROUND:

CAR-T-associated neurotoxicity is extremely frequent with highly variable clinical presentation.

RESEARCH DESIGN AND METHODS:

Disproportionality analysis was conducted leveraging the FDA Adverse Event Reporting System (FAERS), covering the period from 1 January 2017, through 31 March 2023. The reporting odds ratio (ROR) and the information component (IC) were utilized to assess the adverse signals in total/individual CAR-T product. The lower limit of the ROR and IC 95% confidence interval (ROR₀₂₅ and IC₀₂₅) both exceeding threshold value (1 and 0, respectively) was considered a significant signal.

RESULTS:

Of the 60, 730 records associated with CAR-T, 11, 037 (18.17%) pertained to neurological events. Tisagenlecleucel exhibited the highest percentage of death (38.02%) and life-threatening (12.90%) outcomes. Notably, it also displayed the broadest distribution of neurotoxicity. Additionally, distinct adverse signals unique to individual CAR-T products were identified. For instance, paraparesis, cerebral hemorrhage, impaired pupillary reflex, Guillain-Barre syndrome, brain death following tisagenlecleucel; dysarthria, orthostatic hypotension, and spinal cord edema after axicabtagene; parkinsonism, Bell's palsy, and cranial nerve paralysis post ciltacabtagene.

CONCLUSIONS:

Axicabtagene ciloleucel, tisagenlecleucel, brexucabtagene autoleucel, lisocabtagene maraleucel, idecabtagene vicleucel, and ciltacabtagene autoleucel exhibited increased odds of neurotoxicity, with some discrepancies in their characteristics, profiles, and severity.

488

News (Medical) associated with Ciltacabtagene autoleucel

21 Jan 2026

·endpoints.news

J&J praises new FDA guidance to speed development of multiple myeloma drugs

Johnson & Johnson, which has several drugs approved for multiple myeloma, praised the FDA’s just-released draft guidance on how the agency will allow the use of minimal residual disease as a primary endpoint for accelerated approvals of treatments for the blood cancer. The nine-page draft published Tuesday spells out how drug developers can use MRD as an endpoint in several ways, including via a single-arm trial, with the ongoing trial continuing to evaluate progression-free-survival or overall survival to support a full approval. An FDA advisory committee in 2024 voted unanimously to allow the use of MRD as an endpoint. J&J pioneered much of the evidence behind the use of MRD, EVP John Reed said on Wednesday’s earnings call, “so we’re excited that that is an option.” “We are mindful, however, that it’s only an option in the United States. So we, at this point, will still have to deliver progression-free and overall survival data for other territories,” he said. The FDA’s draft says multiple myeloma makes up about 18% of all blood cancers in the US and that 20 new drugs or biologics have been approved since 2003. That’s helped push overall survival to those newly diagnosed to seven to 10 years, or about twice as long as in the early 2000s. J&J’s second-line multiple myeloma treatment Darzalex brought in more than $14 billion last year, the company reported, while its more recently approved second-line treatment Carvykti became a blockbuster for the first time in 2025. The company’s potential combined treatment of Tecvayli and Darzalex in December also scored a new voucher from the FDA that expedites the combo’s review to one to two months. “Vigilant FDA leaders just saw an impressive multiple myeloma trial result” published ahead of the American Society of Hematology conference in Orlando, FL, Commissioner Marty Makary wrote on X last month. Agency experts conferred and “contacted the company THE NEXT DAY to issue them a national priority voucher.” J&J also said it “will be speaking with the agency about opportunities to accelerate some of our development” in multiple myeloma, following the release of the draft guidance and positive ODAC vote . “And in that regard, I think a place where this could be particularly apropos is with our new trispecific antibody for myeloma,” Reed added. The first clinical data for J&J’s potential trispecific antibody, known as JNJ-5322, showed a 100% overall response rate, according to data published in May.

Clinical ResultAccelerated Approval

21 Jan 2026

·firstwordpharma.com

FDA sets draft rules for using MRD, complete response to speed myeloma drug approvals

In a newly released draft guidance, the FDA laid out how drugmakers can lean on minimal residual disease (MRD) and complete response (CR) as primary endpoints to accelerate multiple myeloma therapies toward approval.The FDA noted that overall response rates (ORRs) with new therapies now routinely exceed 60-70% in relapsed disease and 90% in newly diagnosed patients. That success has blunted the usefulness of ORR as a metric to decide accelerated approvals because proving statistically significant differences now means companies have to conduct "infeasibly large" trials. "More sensitive response assessments will allow for continued expeditious drug development," the FDA said.MRD are the tiny traces of cancer cells that can linger in the bone marrow even after a patient appears to be in remission. An FDA advisory panel in 2024 unanimously endorsed using MRD negativity as a surrogate endpoint for myeloma trials after two meta-analyses showed that MRD-negative status strongly correlates with better progression-free survival (PFS) and overall survival (OS).According to the draft guidance, MRD data from single-arm trials can support accelerated approval, though "randomised trials are preferred, as they provide robust assessments for comparative safety" and allow ongoing evaluation of longer-term outcomes like PFS or OS. Sponsors should also "adequately justify the assumed magnitude" of treatment difference for MRD negativity between arms, with MRD assessed at a threshold of at least 1 in 105 residual tumour cells. Additionally, the FDA noted that MRD as an endpoint is appropriate only in specific patient populations and disease settings, saying there isn't enough data currently to consider it in the maintenance therapy or in populations such as smouldering multiple myeloma.Meanwhile, the FDA said CR is a recognised prognostic biomarker, as patients who achieve CR have better long-term outcomes, based on pooled analysis of clinical trial data. While the principles that underpin using MRD as an endpoint also apply to CR, there are some specific considerations, including the need for adequate follow-up in order to establish the durability of CR.J&J 'excited' about optionJohnson & Johnson — which markets several myeloma therapies, including CD38-targeting antibody Darzalex (daratumumab), BCMA-targeting CAR-T cell therapy Carvykti (ciltacabtagene autoleucel) and bispecific antibodies like Tecvayli (teclistamab) and Talvey (talquetamab) — welcomed the new guidance on an earnings call Wednesday."Much of the evidence behind that, frankly, was pioneered by J&J over the years, so we're excited that [MRD] is an option," said John Reed, executive vice president, innovative medicine, R&D. "A place where this could be particularly apropos is with our new trispecific antibody for myeloma, ramantamig (JNJ-79635322), which brings the features of both [Tecvayli] and [Talvey] into a single molecule."However, as this only applies to the US, Reed said the company will still have to deliver PFS and OS data for other territories, "so I suspect that will continue to be an element of our protocols."Comments on the draft can be submitted to the FDA until March 23.

ImmunotherapyAccelerated ApprovalCell Therapy

21 Jan 2026

·www.biopharmadive.com

J&J eyes $100B in sales amid gains for cancer, immune drugs

Dive Brief:Johnson & Johnsons sales rose 9.1% in the fourth quarter to $24.6 billion, as demand for new medicines helped make up for plummeting revenue from the blockbuster drug Stelara.Next years sales should increase to between $100 billion and $101 billion, up from $94.2 billion last year, J&J said Wednesday. The company forecast adjusted earnings per share of between $11.43 and $11.63 for 2026.The fourth-quarter sales figure beat the Wall Street consensus by 2%, Leerink Partners analyst David Risinger wrote in a note to clients. And J&Js guidance for the year was just marginally above consensus, with increased sales held back by higher costs, he added.Dive Insight:Investors appeared unimpressed with J&Js report, sending the companys shares down 1% in early trading Wednesday. Even as CEO Joaquin Duato trumpets the strongest portfolio in our history, J&J is fighting through concerns about the loss of exclusivity for top-selling drugs, litigation over talcum powder and sales for several key drugs that fell short of expectations in the fourth quarter.The most pressing concern for J&Js portfolio is the autoimmune drug Stelara, which raked in more than $10 billion in 2024 but has been on a downward slope with the loss of U.S. patent protection in 2023. In the fourth quarter, Stelara sales dropped 55% to $766 million in the U.S.; worldwide revenue fell 48% to $1.23 billion for the period.Meanwhile, a U.S. patent expiration looms in 2029 for the cancer drug Darzalex, which brought in $14.4 billion last year as sales rose 23%.J&J isnt alone in facing the patent cliff. The company has tried to compensate in part by looking outside, paying close to $15 billion to buy psychiatric drug developer Intra-Cellular Therapies and $3 billion to acquire the oncology startup Halda Therapeutics. J&J also spent $1.25 billion to take over Yellow Jersey Therapeutics in 2024, though the main draw of that acquisition an eczema drug failed in testing in December.J&J is also putting more focus on cancer treatments. The goal is to become the No. 1 oncology company, reaching $50 billion by the end of the decade, Duato told analysts and investors on a conference call. We are very confident on our progress there in our pipeline.The company has worked to expand sales of the cell therapy Carvykti by winning approval for use in earlier in treating multiple myeloma. And just last month, J&J shared impressive data on another multiple myeloma treatment, Tecvayli. Carvykti sales soared 66% to $555 million in the fourth quarter, though that was still shy of Wall Streets expectations, Risinger said. Tecvayli, whose revenue rose 21% to $176 million in the quarter, also fell short of estimates.J&J is placing bets in immunology, too. A partnership with Protagonist Therapeutics has yielded a psoriasis pill thats nearing approval and that the company sees becoming a new blockbuster, Duato said. Its being evaluated in other autoimmune conditions as well.Like rivals, J&J is additionally trying to neutralize political threats to its business. Earlier this month, the company reached an agreement with the White House on drug pricing, becoming one of more than a dozen drugmakers to fall in line amid tariff threats from President Trump. Even so, J&J expects its tariff costs to more than double to about $500 million in 2026, the Wall Street Journal reported. '

AcquisitionCell TherapyDrug ApprovalImmunotherapy

100 Deals associated with Ciltacabtagene autoleucel

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Refractory Multiple Myeloma	Japan	Janssen Pharmaceutical KK	03 Aug 2022
Relapse multiple myeloma	Japan	Janssen Pharmaceutical KK	03 Aug 2022
Multiple Myeloma	United States	Nanjing Legend Biotech Co., Ltd.	28 Feb 2022
Multiple Myeloma	United States	Janssen Biotech, Inc.	28 Feb 2022

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Smoldering Multiple Myeloma	Phase 2	United States	Janssen Research & Development LLC	19 Apr 2023
Recurrent Multiple Myeloma	Phase 2	-	Nanjing Legend Biotech Co., Ltd.	02 Oct 2015
Extramedullary Plasmacytoma	Phase 1	Australia	Janssen LP	08 Dec 2023

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04181827 \| NCT03548207 (CARTITUDE-1, ASH2025) Manual	Phase 3	Multiple Myeloma	176	Ciltacabtagene autoleucel	wcxooyrpyt(xxsvszxuna) = kwxyjozhjh fhlitdjlfe (phvamsgkmj, 58.8 - 80.2) View more	Positive	06 Dec 2025
				Standard-of-care	wcxooyrpyt(xxsvszxuna) = rlydsiunnx fhlitdjlfe (phvamsgkmj, 31.3 - 54.5)
CARTITUDE-4 (ASH2025)	Phase 3	Multiple Myeloma Second line	67	Ciltacabtagene autoleucel (cilta-cel)	jjmajcwksf(cqchdlxlkd) = ehekjnvhnd lvlpvzoblq (cfsewekugf )	Positive	06 Dec 2025
ASH2025	Not Applicable	Multiple Myeloma \| Lymphoma	13,581	axicabtagene ciloleucel (axi-cel)	algwedegha(skqizycrxo) = fnzozrsnfq pllobngzkb (phltjzemnr ) View more	Positive	06 Dec 2025
				ciltacabtagene autoleucel (cilta-cel)	algwedegha(skqizycrxo) = hdlgmmimfv pllobngzkb (phltjzemnr ) View more
NCT04181827 (CARTITUDE-4, ASH2025)	Phase 3	Relapse multiple myeloma	208	Ciltacabtagene autoleucel (cilta-cel)	myupkhwmfo(paoldpbuog) = kwkibumjfp ewbvtsmhoo (rikckargtn ) View more	Positive	06 Dec 2025
				Belantamab mafodotin+bortezomib+dexamethasone (BVd)	myupkhwmfo(paoldpbuog) = oztpralvpx ewbvtsmhoo (rikckargtn ) View more
ASH2025	Not Applicable	Relapse multiple myeloma	40	OOS/MF cilta-cel	rtwbjnhjcy(unwjinpxde) = xcmqaclwte vlbkhzkrot (bscbakwhba ) View more	Positive	06 Dec 2025
ASH2025	Not Applicable	Multiple Myeloma	174	Ciltacabtagene autoleucel (cilta-cel) in second to fourth line (2L-4L)	quurnisgrh(avoowdgkhs) = tcmybwluaf kyxsbdmbdi (iiaiziduaz ) View more	Positive	06 Dec 2025
				Ciltacabtagene autoleucel (cilta-cel) in fifth line or later (5L+)	quurnisgrh(avoowdgkhs) = goyowatvey kyxsbdmbdi (iiaiziduaz ) View more
ASH2025	Not Applicable	Relapse multiple myeloma	135	Idecabtagene vicleucel (ide-cel)	llsxeispzp(ernfkpyufi) = nchidkgivk clkzcfrpwi (kojqgylvva ) View more	Positive	06 Dec 2025
				Ciltacabtagene autoleucel (cilta-cel)	llsxeispzp(ernfkpyufi) = yykxsjfvdu clkzcfrpwi (kojqgylvva ) View more
ASH2025	Not Applicable	Multiple Myeloma	233	Idecabtagene vicleucel (ide-cel)	zikcgqhvib(ehdxmqbciz) = hayvsmxraw dprygfbbev (kffiytfxss ) View more	Positive	06 Dec 2025
				Ciltacabtagene autoleucel (cilta-cel)	zikcgqhvib(ehdxmqbciz) = wwoiwripoi dprygfbbev (kffiytfxss ) View more
ASH2025	Not Applicable	Multiple Myeloma	76	Idecabtagene vicleucel	ogismpyykc(ubesaxwdgm) = gvylvdwwgc erxvkfbjfz (jeoklrqezf, 293 - 1038) View more	Positive	06 Dec 2025
				Ciltacabtagene autoleucel	ogismpyykc(ubesaxwdgm) = tmdjyhwrjt erxvkfbjfz (jeoklrqezf, 460 - 2616) View more
ASH2025	Not Applicable	Multiple Myeloma	198	Ide-cel	uqkxwsclri(bzofkouxrb) = qpctwwubbo nnxrwxmbxy (okaasfgwdk ) View more	Positive	06 Dec 2025
				Cilta-cel	uqkxwsclri(bzofkouxrb) = fflyhqmhjo nnxrwxmbxy (okaasfgwdk ) View more

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Ciltacabtagene autoleucel

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