RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Breakthrough Therapy (China), Priority Review (Canada)

Structure/Sequence

Sequence Code 1324438509

Source: *****

Clinical Trials associated with Brexucabtagene Autoleucel

NCT06553872

/ RecruitingPhase 2IIT

A Phase 2, Open-Label, Randomized Study of Pirtobrutinib and Brexucabtagene Autoleucel in Patients With Relapsed or Refractory Mantle Cell Lymphoma

This is a phase 2, open-label, randomized, multicenter clinical trial in patients with relapsed/refractory mantle cell lymphoma (R/R MCL) who meet the criteria for standard-of-care FDA label for CD19 CAR T-cell therapy with brexucabtagene autoleucel (brexu-cel).

Start Date23 Aug 2024

Sponsor / Collaborator

H. Lee Moffitt Cancer Center & Research Institute, Inc.

[+1]

NCT06253663

/ Active, not recruitingPhase 2

A Phase 2 Multicenter Study Evaluating the Safety and the Efficacy of KTE-X19 in Adult Japanese Subjects With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia

The goal of this clinical study is to learn more about KTE-X19, and how safe and effective it is in adult Japanese participants with relapsed/refractory (r/r) Mantle Cell Lymphoma (MCL) or r/r B-precursor Acute Lymphoblastic Leukemia (B-ALL).
The primary objectives of this study are to evaluate the efficacy of KTE-X19, as measured by:
* Objective response rate (ORR) per investigator assessment, in adult Japanese participants with r/r MCL
* Overall complete remission (OCR) defined as complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) per investigator assessment, in adult Japanese participants with r/r ALL

Start Date18 Mar 2024

Sponsor / Collaborator

Kite Pharma, Inc.

NCT06482684

/ RecruitingPhase 2IIT

Early Treatment Intensification in Patients With High Risk Mantle Cell Lymphoma Using CAR-T-cell Treatment After an Abbreviated Induction Therapy With Rituximab and Ibrutinib and 6 Months Ibrutinib Maintenance (Arm A) as Compared to Standard of Care Induction and Maintenance (Arm B)

First-line CAR-T-cell consolidation after an abbreviated induction with 2 cycles of Rituximab and Ibrutinib prior to CAR-T-cell treatment and followed by 6 months of maintenance with Ibrutinib in patients with high risk MCL.

Start Date15 Feb 2024

Sponsor / Collaborator

Ludwig-Maximilians-Universität München

[+1]

100 Clinical Results associated with Brexucabtagene Autoleucel

100 Translational Medicine associated with Brexucabtagene Autoleucel

100 Patents (Medical) associated with Brexucabtagene Autoleucel

148

Literatures (Medical) associated with Brexucabtagene Autoleucel

01 Nov 2025·Drug information journal

Post-marketing Safety Assessment of CAR T-cell Therapies: Analysis of Individual Case Safety Reports in the VigiBase

Article

Author: AlFadel, Nouf S ; AlRasheed, Meshael M ; AlOrf, Nora N ; AlHawas, Solaiman M ; AlHarbi, Fawaz F

PURPOSE:

Chimeric Antigen Receptor (CAR)-T cell therapies have emerged as potential therapy for hematological malignancies, however, their safety profiles should be monitored after approval. Therefore, we aimed in this study to explore and analyze individual case safety report (ICSRs) associated with CAR-T cell therapies and reported to the World Health Organization (WHO) global database (VigiBase).

METHODS:

A retrospective pharmacovigilance study was conducted to describe and characterize Adverse drug reactions (ADRs) reported to Vigibase from inception to March 31st, 2024 and associated with use of the following CAR-T cell therapies: Tisagenlecleucel, Axicabtagene ciloleucel, Brexucabtagene autoleucel, Lisocabtagene maraleucel, Idecabtagene vicleucel, and Ciltacabtagene autoleucel.

RESULTS:

A total of 11,693 ICSRs were identified with the use of CAR-T cell therapies in VigiBase (Axicabtagene ciloleucel (N = 5668, 48.5%), Tisagenlecleucel (N = 3364, 28.8%), Brexucabtagene autoleucal (N = 1027, 8.8%), Lisocabtagene maraleucel (N = 304, 2.6%), Idecabtagene vicleucel (N = 579, 4.9%), and Ciltacabtagene autoleucel (N = 751, 6.4%)). ICSRs completeness score was averaged between 0.2 and 0.57 among all included products and the majority of reported ADRs were serious (67-91%). Among serious ADRs, death was reported with an average percentage of (8.8-21.5%). The majority of ADR reports with fatal outcome occurred in accordance with their approved indications. About 18% of fatal events reported with Tisagenlecleucel as the suspected drug were in the pediatric population.

CONCLUSION:

Our study provides an overall exploration of the post-marketing safety profiles of currently approved CAR-T cell therapies. The significant proportion of fatalities occurred in accordance with approved indications, emphasizes the need for ongoing investigation into ADRs with fatal outcomes, particularly in the pediatric population.

13 Oct 2025·Oncoscience

Targeted therapies and resistance mechanisms in lymphoma: Current landscape and emerging solutions

Review

Author: Afshan, Roshan ; Sridhar, Shruthi ; Tiwari, Bishal

Lymphomas represent a diverse group of hematologic malignancies with variable clinical behavior and underlying biology. The fifth edition of the WHO classification (WHO-HAEM5, 2022) provides an updated, lineage-based framework to categorize lymphoid neoplasms, integrating immunophenotypic, genetic, and clinical features. With advancements in molecular profiling and immunotherapy, targeted treatments have transformed the therapeutic landscape of both Hodgkin and non-Hodgkin lymphomas. This review delineates the critical role of cell surface and intracellular receptors-including CD19, CD20, CD30, PD-1, and CCR4-in lymphoma pathogenesis and as therapeutic targets. We comprehensively evaluate FDA-approved targeted agents, including monoclonal antibodies (rituximab, brentuximab vedotin, obinutuzumab, mogamulizumab), immune checkpoint inhibitors (nivolumab, pembrolizumab), CAR T-cell therapies (axi-cel, tisa-cel, liso-cel, brexu-cel), bispecific T-cell engagers (mosunetuzumab, epcoritamab), and small-molecule inhibitors (ibrutinib, idelalisib, venetoclax). Each class is appraised for mechanism of action, efficacy, and safety in key lymphoma subtypes. Despite significant progress, therapeutic resistance remains a major obstacle. We categorize resistance mechanisms as antigen loss or modulation, pathway reactivation, immune microenvironment adaptation, and genetic/epigenetic evolution. Examples include CD19 antigen loss post-CAR-T therapy, BTK mutations conferring ibrutinib resistance, and immune checkpoint upregulation impairing T-cell function. Emerging strategies to counteract resistance include rational combination therapies, dual-targeted CAR constructs, next-generation bispecific antibodies, and precision-guided immunotherapy. Integration of biomarker profiling, real-time resistance monitoring, and novel immune-engineering approaches offers potential to overcome current therapeutic limitations. In conclusion, understanding the molecular basis of lymphoma and resistance mechanisms is critical to optimizing targeted therapy. This review synthesizes current evidence to inform clinical decision-making and outlines future directions for durable, personalized lymphoma care.

26 Aug 2025·Blood Advances

Outcomes of brexucabtagene autoleucel in patients with relapsed/refractory acute lymphoblastic leukemia with CNS involvement

Article

Author: Roloff, Gregory W. ; Guzowski, Caitlin ; Muffly, Lori S. ; Connor, Matthew ; Mathews, John ; Gupta, Vishal K. ; Malik, Shahbaz A. ; Leonard, Jessica T. ; Shah, Bijal D. ; Kumaran, Muthu ; Cassaday, Ryan D. ; Dykes, Kaitlyn C. ; Dekker, Simone E. ; O'Connor, Timothy E. ; Lee, Catherine J. ; Koura, Divya ; Battiwalla, Minoo ; Muhsen, Ibrahim N. ; Solh, Melhem M. ; Valtis, Yannis ; Hill, LaQuisa C. ; Tsai, Stephanie B. ; Faramand, Rawan ; Park, Jae H. ; Othman, Tamer ; Oliai, Caspian H. ; Sutherland, Katherine C. ; Mountjoy, Luke ; Kopmar, Noam E. ; Miller, Katharine ; Logan, Aaron C. ; Majhail, Navneet ; Frey, Noelle ; Schwartz, Marc ; Sasine, Joshua P. ; Zhang, Amy ; Mercadal, Santiago ; Ahmed, Mohamed ; Shaughnessy, Paul ; Jeyakumar, Nikeshan ; Aldoss, Ibrahim

Abstract:

Patients with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL) with central nervous system (CNS) involvement (CNS B-ALL) have poor outcomes and were frequently excluded from CD19-targeting chimeric antigen receptor (CAR) T-cell clinical trials. The efficacy and safety of brexucabtagene autoleucel (brexu-cel) in adults with R/R B-ALL was established by the ZUMA-3 trial, which excluded patients with advanced or symptomatic CNS involvement. In this retrospective multicenter analysis, we investigated the safety and efficacy of brexu-cel in patients with CNS B-ALL using data from the ROCCA (Real-World Outcomes Collaborative for CAR T in ALL) consortium. Of 189 patients who received infusion, 31 had CNS-2 (presence of blasts in cerebrospinal fluid with <5 white blood cells [WBCs] per μL) or CNS-3 (presence of blasts with >5 WBCs per μL and/or clinical signs/symptoms) disease before apheresis and are the focus of this report. The median age was 46.5 years (range, 24-76), and 58.1% were male. Most (87.1%) received bridging therapy. After brexu-cel, 21 of 24 patients with CNS restaging (87.5%) achieved CNS-1. Additionally, 28 of 30 evaluable patients achieved marrow complete remission; 25 were measurable residual disease negative. No statistically significant differences were seen in progression-free survival or overall survival after brexu-cel among patients with or without CNS involvement. Similarly, grade 3/4 immune effector cell–associated neurotoxicity syndrome occurred similarly in patients with (35.5%) and without (30%) CNS disease. In conclusion, our data suggest that brexu-cel results in high response rates in patients with CNS B-ALL, with toxicity comparable with that in patients without CNS involvement.

231

News (Medical) associated with Brexucabtagene Autoleucel

05 Dec 2025

·www.fiercepharma.com

BMS scores 5th indication for Breyanzi with FDA marginal zone lymphoma nod

Bristol Myers Squibb's Breyanzi has scored an FDA approval in its fifth cancer type, marginal zone lymphoma. With FDA approval to treat marginal zone lymphoma (MZL), Bristol Myers Squibb’s Breyanzi has become the first CAR-T therapy in the indication, as well as the first CAR-T to reach the market for five different types of blood cancer.The U.S. regulator has endorsed the one-time infused CD19-directed treatment for adult patients with relapsed or refractory MZL who have received at least two lines of prior therapy.Breyanzi, which broke through in 2021 with a nod for large B-cell lymphoma, has also been blessed by the U.S. regulator to treat mantle cell lymphoma (MCL) and follicular lymphoma (FL), as well as chronic lymphocytic lymphoma (CLL) and small lymphocytic lymphoma (SLL).The latest endorsement gives BMS a leg-up on Gilead’s CD19-directed duo of Yescarta and Tecartus, which have been approved for a combined four blood cancer indications, with the latter CAR-T owning a unique nod in B-cell acute lymphoblastic leukemia.As for MZL, which accounts for roughly 7% of all non-Hodgkin's lymphoma cases, the slow-growing disorder develops when white blood cells clump together in the lymph nodes or organs. Remission is often accomplished with initial therapy, but relapse is common and can occur often and over the span of several years. Some MZL cases can progress into large B-cell lymphoma, which is more aggressive.“Today’s approval represents a major advancement in precision medicine, essentially turning the patient’s immune system into a more effective tool to treat MZL,” Vinay Prasad, M.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER), said in a release.Setting Breyanzi up for approval included results from the phase 2 Transcend FL trial, which enrolled 66 MZL patients and reported a 95% overall response rate, with 62% of participants achieving a complete response. Of the responders, 90% maintained their response through 24 months.With MZL, there is a “pressing need for new treatment options with durable outcomes,” according to study investigator M. Lia Palomba, M.D., a lymphoma and cell therapy specialist at the Memorial Sloan Kettering Cancer Center.Palomba characterized the approval as “a significant advancement in redefining the treatment landscape and providing patients with an option that has demonstrated high rates of responses with an established safety profile.” In the MZL cohort of the study, any grade cytokine release syndrome (CRS) occurred in 76% of patients. Any grade nervous system disorders included headache (21%), tremor (21%), encephalopathy (21%), dizziness (16%), and aphasia (10%), BMS said.With Breyanzi, BMS is playing catch-up with Gilead, which scored its first CAR-T approval with Yescarta in 2017. The treatment became a blockbuster in 2022 and achieved sales of $1.6 billion last year, in addition to sales of $403 million for Tecartus, which reached the market in 2020. Gilead’s revenues from the two CAR-Ts are now in decline, however, with third-quarter sales down for Yescarta by 10% and for Tecartus by 15%. Their combined sales were $432 million for the period.Meanwhile, BMS reported revenues from Breyanzi were up 58% to $359 million in Q3. With sales of $907 million so far this year, Breyanzi is set to become a blockbuster for the first time.BMS gained Breyanzi with its $74 billion acquisition of Celgene in 2019. The deal came less than a year after Celgene gained the treatment with its $9 billion buyout of Juno Therapeutics.

Clinical ResultDrug ApprovalImmunotherapyAcquisitionCell Therapy

25 Nov 2025

·www.businesswire.com

BostonGene to Showcase Transformative Impact of AI-Driven Profiling with Six Abstracts at the 67th American Society of Hematology Annual Meeting & Exposition

WALTHAM, Mass.--(BUSINESS WIRE)--BostonGene, a leading provider of AI-driven molecular and immune profiling solutions, today announced the selection of two abstracts for oral presentation, three abstracts for poster presentation and one abstract for online publication at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, which will be held December 6-9, 2025, in Orlando, Florida. BostonGene will exhibit in booth #1581. Our AI-powered tools, such as the Lymphly classifier and our B-cell-based marker provide the molecular precision required to de-risk clinical programs and ensure the right drug reaches the right patient subpopulation. “The research we are presenting highlights the critical need for advanced patient stratification in hematology. Our AI-powered tools, such as the Lymphly classifier and our B-cell-based marker provide the molecular precision required to de-risk clinical programs and ensure the right drug reaches the right patient subpopulation. This is about moving beyond conventional diagnostics to build a foundational, integrated approach for effective companion diagnostics and unified monitoring in drug studies,” said Nathan Fowler, MD, Chief Medical Officer at BostonGene. Details of the presentations are below: Oral presentations: Abstract number: 14219 Title: Acalabrutinib plus rituximab followed by brexucabtagene autoleucel for frontline treatment of high-risk mantle cell lymphoma: The WINDOW-3 clinical trial Date & time: December 7 — 5:45 PM – 6:00 PM Location: Tangerine Ballroom F2 Speaker: Preetesh Jain, MD, DM, PhD, The University of Texas MD Anderson Cancer Center The WINDOW-3 clinical trial evaluating acalabrutinib plus rituximab followed by brexucabtagene autoleucel CART in patients with high-risk mantle cell lymphoma (MCL) demonstrated strong efficacy and encouraging survival outcomes. BostonGene’s AI-based immunoprofiling revealed CART therapy in high-risk MCL led to drastic immune remodeling, with specific CART-cell types and memory subsets correlating with toxicity, indicating a key role in immune system monitoring for treatment-related toxicities. Research conducted in collaboration with MD Anderson Cancer Center Abstract number: 7242 Title: A phase 1b trial of the EZH2 inhibitor tazemetostat combined with CAR T cell therapy in B cell lymphomas Date & time: December 8 — 5:00 PM – 5:15 PM Location: OCCC - Tangerine Ballroom F3-4 Speaker: Samuel Yamshon, MD, Weill Cornell Medical College Based on the premise that inhibition of EZH2 prevents T cell exhaustion and modulates T cell activity, the phase I study administered tazemetostat with CAR-T in patients with B-cell lymphoma. The combination resulted in an impressive 100% response rate with no signal of additional toxicity. BostonGene’s novel immunophenotyping is being performed to demonstrate the immune modulatory effects of combination therapy, providing mechanistic rationale for further combination approaches. Research conducted in collaboration with Weill Cornell Medical Center Poster presentations: Abstract number: 1837 Title: Refining diffuse large B-cell lymphoma subtyping using Lymphly, an evidence-based classifier Date & time: December 6 — 5:30 PM - 7:30 PM Speaker: Nikita Kotlov, MS, BostonGene BostonGene developed Lymphly, an AI hierarchical classifier for diffuse large B-cell lymphoma (DLBCL), to resolve genetically heterogeneous and atypical tumors often missed by existing classifications. By integrating pathway-relevant genomic alterations into a transparent framework, Lymphly distinguishes both established and emerging subtypes, including high-risk TP53+ and MYC+ groups, offering refined molecular stratification for clinical trial design, treatment selection and targeted therapy development. Abstract number: 2692 Title: A genetic comparison of Epstein-Barr virus-associated polymorphic lymphoproliferative disorder and diffuse large B cell lymphoma Date & time: December 6 — 5:30 PM - 7:30 PM Speaker: Jennifer Chapman, MD, University of Miami and Sylvester Comprehensive Cancer Center BostonGene’s multimodal platform with integrated genomic, transcriptomic and immune data was used to analyze and compare Epstein-Barr virus (EBV)-positive lymphoproliferative disorder and diffuse large B-cell lymphoma. This study underscored the complexity of EBV-driven diseases and highlighted the need for improved classification strategies, demonstrating the potential of BostonGene’s AI-powered platform to advance precision diagnostics and improve patient outcomes. Research done in collaboration with the University of Miami Sylvester Cancer Institute Abstract number: 12996 Title: An immunometabolic companion biomarker to enhance FDG-PET interpretation and guide frontline therapy in follicular lymphoma Date & time: December 8 — 6:00 PM - 8:00 PM Speaker: Joshua W.D. Tobin, MD, MSc, Princess Alexandra Hospital, Mater Research Institute In collaboration with MD Anderson and several hospitals and academic institutions in Australia, BostonGene leveraged its multimodal pipeline to design a B cell-based candidate biomarker in patients with follicular lymphoma treated with bendamustine-based immunochemotherapy (ICT). Represented by centroblast (CB) scores, this biomarker identifies patients with high-grade disease who may respond to bendamustine-based ICT. Independent of and additive to pre-treatment PET, the CB score was highly prognostic suggesting a potential role for patient stratification. Research done in collaboration with the University of Queensland Online only Title: Replacing FISH with a comprehensive integrated approach for tumor genotyping and immune monitoring in multiple myeloma BostonGene’s integrated platform, combining whole exome and RNA sequencing of tumor (CD138⁺ plasma cells) and peripheral blood samples, reproduced FISH-detectable abnormalities (e.g., del17p/TP53 deletion or t(11;14) translocations) and revealed additional mutations, structural variants and immune signatures in multiple myeloma patients, including low-tumor-content samples. By overcoming limitations of conventional FISH, BostonGene’s approach may provide a scalable solution and broader diagnostic capabilities for unified genomic and immune monitoring in clinical trials and patient care. Research done in collaboration with the University of Miami Sylvester Cancer Institute In addition to the poster presentations, the abstracts are published online in the November supplemental issue of Blood. About BostonGene Corporation BostonGene is redefining cancer patient care and drug development through the integration of omnimodal data and artificial intelligence. Built and validated through an extensive real-world clinical testing network, BostonGene’s Foundation Model of cancer and the immune system integrates genomic, transcriptomic, and immune data with clinical outcomes to generate biologically grounded, actionable insights. These insights enable biopharma partners to design and de-risk trials, identify novel targets, and optimize therapeutic response prediction across all stages of development while simultaneously improving patient care through clinically integrated innovation. For more information, visit www.BostonGene.com.

ImmunotherapyClinical ResultPhase 1Cell TherapyASH

25 Nov 2025

·www.pharmaceutical-technology.com

UK-developed leukaemia cell therapy to be offered on NHS

NICE took ALL’s severity into account when weighing up the treatment’s benefits. Credit: pinkeyes via Shutterstock.com. A UK-developed cell therapy to treat a form of leukaemia has been greenlit for use on England’s National Health Service (NHS). The National Institute for Health and Care Excellence (NICE), the NHS spending watchdog, recommended Aucatzyl (obecabtagene autoleucel) for the treatment of relapsed or refractory B-cell acute lymphoblastic leukaemia (ALL). ALL is a rare and aggressive type of blood and bone marrow cancer, with the B-cell subtype being more common than T-cell leukaemia. Standard treatment for the condition involves chemotherapy and steroids, though targeted treatments are also approved for NHS use. NICE stated that its independent committee applied greater weighting to the benefits that the new therapy would offer over current treatments due to B-cell ALL’s severity. Developed by University College London spinout Autolus Therapeutics, Aucatzyl is a CAR-T treatment. This personalised modality involves genetically modifying the patient’s own T cells to recognise and fight cancer cells. Autolus said it will launch Aucatzyl in England and Wales imminently, with plans also in place to pursue patient access in Scotland. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence NICE’s director of medicines evaluation Helen Knight said: “This drug has the potential to offer a more effective and less toxic alternative to standard treatments, with fewer side effects. This could potentially be a life-saving drug, which will make a huge difference to people’s lives, including spending less time in hospital.” Evidence from a clinical trial has shown high rates of remission in patients whose cancer has either returned after treatment or failed to respond to initial therapy. In the pivotal FELIX study (NCT04404660), 77% of those who had at least one Aucatzyl infusion went into remission. NICE said evidence suggests that Autolus’ drug improves survival when compared to other immunotherapies. NICE reports that Aucatzyl works just as well as Kymriah (tisagenlecleucel), another CAR-T developed by Novartis that was recommended for ALL patients on the NHS in 2024. Kymriah is available for people aged 25 years and under, while Aucatzyl is recommended for those aged 26 years and over. A third CAR-T, Kite Pharma’s Tecartus (brexucabtagene autoleucel), is also available to ALL patients aged 25 years and over. The NICE recommendation is the latest vote of confidence from UK regulatory agencies on advanced therapies, despite a handful of pharma companies withdrawing from the sector this year. In August 2024, the Association of the British Pharmaceutical Industry (ABPI) called on the NHS to take more action to adopt more cell and gene therapies, highlighting that a one-time treatment can save the healthcare system’s money over a patient’s lifetime, despite the high upfront cost. NICE has since greenlit several new advanced therapies, including Casgevy (exagamglogene autotemcel) for the treatment of sickle cell disease. The therapy was the world’s first approved medicine using the CRISPR/Cas9 gene editing system. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has also outlined major changes to regulation for rare disease treatments, saying it will speed up development pathways so therapies can reach patients sooner. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free eBook Navigating cell therapy process development The cell therapy manufacturing sector is rapidly evolving, driven by the need to balance innovative process development with rigorous GMP standards. This eBook, brought to you by industry leaders Cytiva, explores how biotech firms can address common challenges — including minimizing contamination risks from manual processes, overcoming resource limitations, and creating scalable, robust designs. Industry experts discuss strategies including automation, strategic outsourcing, and flexible equipment selection to streamline processes and reduce regulatory risks. To unlock expert insights on optimizing your cell therapy pathway from clinical development to commercialization, fill in your details now. Thank you. You will receive an email shortly. Please check your inbox to download the eBook. By Cytiva Thematic You have a right to withdraw your consent at any time, by clicking here . We may still continue to send you service-related and other non-promotional communications. For more information relating to our privacy practices, we invite you to review our privacy policy . Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now

Cell TherapyImmunotherapyDrug Approval

100 Deals associated with Brexucabtagene Autoleucel

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma	Australia	Gilead Sciences Pty Ltd.	30 Sep 2022
Mantle cell lymphoma recurrent	European Union	Kite Pharma EU BV	14 Dec 2020
Mantle cell lymphoma recurrent	Iceland	Kite Pharma EU BV	14 Dec 2020
Mantle cell lymphoma recurrent	Liechtenstein	Kite Pharma EU BV	14 Dec 2020
Mantle cell lymphoma recurrent	Norway	Kite Pharma EU BV	14 Dec 2020
Mantle cell lymphoma refractory	European Union	Kite Pharma EU BV	14 Dec 2020
Mantle cell lymphoma refractory	Iceland	Kite Pharma EU BV	14 Dec 2020
Mantle cell lymphoma refractory	Liechtenstein	Kite Pharma EU BV	14 Dec 2020
Mantle cell lymphoma refractory	Norway	Kite Pharma EU BV	14 Dec 2020
Acute Lymphoblastic Leukemia	United States	Kite Pharma, Inc.	24 Jul 2020
Mantle-Cell Lymphoma	United States	Kite Pharma, Inc.	24 Jul 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Burkitt Lymphoma	Phase 2	United States	Kite Pharma, Inc.	01 Nov 2022
Burkitt Lymphoma	Phase 2	Austria	Kite Pharma, Inc.	01 Nov 2022
Burkitt Lymphoma	Phase 2	France	Kite Pharma, Inc.	01 Nov 2022
Burkitt Lymphoma	Phase 2	Germany	Kite Pharma, Inc.	01 Nov 2022
Burkitt Lymphoma	Phase 2	Italy	Kite Pharma, Inc.	01 Nov 2022
Burkitt Lymphoma	Phase 2	Netherlands	Kite Pharma, Inc.	01 Nov 2022
Burkitt Lymphoma	Phase 2	Spain	Kite Pharma, Inc.	01 Nov 2022
Burkitt Lymphoma	Phase 2	Switzerland	Kite Pharma, Inc.	01 Nov 2022
Hairy Cell Leukemia	Phase 2	United States	Kite Pharma, Inc.	01 Nov 2022
Hairy Cell Leukemia	Phase 2	Austria	Kite Pharma, Inc.	01 Nov 2022

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2025	Not Applicable	CD19-positive B-cell acute lymphoblastic leukemia Consolidation CD19	46	Brexucabtagene autoleucel (Brexu-cel)	yrnelniojx(efxzysglxa) = Among the 3 pts with G3-4 CRS/ICANS, the peak CAR T expansion was 102, 1270 and 2222 cells/µL mtvxqozcit (ofkkkqkcyp )	-	30 May 2025
EHA2025	Phase 2	-	613	Brexucabtagene Autoleucel (Brexu-cel)	dkodjwvtjw(iefqimlpkw) = rjclbdyril hztoyqnmpb (ozhoneggbb, 85 - 90) View more	-	14 May 2025
ChiCTR2300073872 (PF403, EHA2025)	Phase 2	Recurrent Adult Acute Lymphoblastic Leukemia CD19	32	KTE-X19	cinpatmpop(mthnuyqybp) = kajfvftcli zhqfdtulsg (efrxsljlzf, 62.0% - 90.2%) View more	Positive	14 May 2025
ZUMA-3 (EHA2025)	Phase 2	Precursor B-Cell Lymphoblastic Leukemia-Lymphoma CD19	78	Brexucabtagene Autoleucel (Brexu-Cel)	cjwjuhovtq(aqevcdgazy) = jmirpsgtjz ftzgrctgof (iqrxoplels, 28.4 - 51.3)	Positive	14 May 2025
ZUMA-3 (EHA2025)	Phase 2	Precursor B-Cell Lymphoblastic Leukemia-Lymphoma CD19	78	Prior Blinatumomab	cjwjuhovtq(aqevcdgazy) = hliarletgg ftzgrctgof (iqrxoplels, 12.1 - 40.4)	Positive	14 May 2025
NCT02614066 (ZUMA-3, Pubmed \| Leukemia) Manual	Phase 1/2	Precursor B-Cell Lymphoblastic Leukemia-Lymphoma	78	Brexucabtagene autoleucel	wknjfwpjpj(pvmnzgfnlf) = eqhlafzidr hghhywgvvs (yfepnubbxw, 1.2 - 47.0) View more	Positive	19 Mar 2025
NCT02601313 (ZUMA-2, ASH2024) Manual	Phase 2	Mantle-Cell Lymphoma	74	Brexucabtagene Autoleucel (Brexu-cel) 2x10^6 anti-CD19 CAR T cells/kg	qoodjnlvjo(lduhtlvdjh) = kbaisntzqu srteiujopn (ommapgevob ) View more	Positive	09 Dec 2024
NCT02601313 (ZUMA-2, ASH2024) Manual	Phase 2	Mantle-Cell Lymphoma	74	Brexucabtagene Autoleucel (Brexu-cel) 0.5x10^6 anti-CD19 CAR T cells/kg	qoodjnlvjo(lduhtlvdjh) = myarbtpjrh srteiujopn (ommapgevob, 66.1 - 99.8) View more	Positive	09 Dec 2024
NCT04880434 (ZUMA-2, ASH2024) Manual	Phase 2	Mantle cell lymphoma refractory TP53 Mutation	95	Brexucabtagene Autoleucel	msyodobrjp(fmvfpcamls) = fncmrfmzyk ilzjegizpd (droocbdfkb, 82.5 - 95.9) Met View more	Positive	09 Dec 2024
ASH2024	Not Applicable	Precursor B-Cell Lymphoblastic Leukemia-Lymphoma	-	Brexucabtagene Autoleucel (Brexu-Cel)	qfiotrgpzf(apswxdgkpr) = mklggzmzez ytairdqvjq (bokwqbtcvx, 74 - 84) View more	-	09 Dec 2024
ASH2024	Not Applicable	Refractory B Acute Lymphoblastic Leukemia	-	Brexucabtagene Autoleucel	zhttarphym(vtflokvpcn) = Grade 1-2 ICANS occurring at a significantly higher rate in patients aged 70 and above (44%) compared to 60-69 (20%) and under 60 (20%) bobxctjtgl (vwddhpqovb )	-	08 Dec 2024
ASH2024	Not Applicable	Refractory B Acute Lymphoblastic Leukemia	-	Brexucabtagene Autoleucel (Patients aged 60-69)		-	08 Dec 2024
ASH2024	Not Applicable	Mantle-Cell Lymphoma	-	Brexucabtagene Autoleucel (Peak ALC ≥0.45 × 109/L)	fuvipewzmf(spqtnvuhos) = 100% vs 80% itplpfbxgi (fmxqcohakz ) View more	-	07 Dec 2024
ASH2024	Not Applicable	Mantle-Cell Lymphoma	-	Brexucabtagene Autoleucel (Peak ALC <0.45 × 109/L)		-	07 Dec 2024

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Core Patent

Boost your research with our Core Patent data.

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Clinical Trial

Identify the latest clinical trials across global registries.

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Approval

Accelerate your research with the latest regulatory approval information.

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Brexucabtagene Autoleucel

Overview

Basic Info

Structure/Sequence

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation