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), Regenerative Medicine Advanced Therapy (Japan)

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

158

Literatures (Medical) associated with Brexucabtagene Autoleucel

01 Mar 2026·Transplantation and Cellular Therapy

Immune Effector Cell-Associated HLH-Like Syndrome (IEC-HS) in CAR-T and TCE-Treated Myeloma and B-Cell Malignancies: Insights from a Pharmacovigilance Study

Article

Author: Irfan, Sohaib ; Kamboj, Ishita ; Rahman, Raeef ; Qureshi, Raabia ; Ahmed, Nausheen ; Abdallah, Al-Ola ; Ayoobkhan, Fathima Shehnaz ; Lutfi, Forat ; Mahmoudjafari, Zahra ; McGuirk, Joseph ; Vojjala, Nikhil

Chimeric antigen receptor T-cell therapy (CAR-T) and T-cell engager antibody (TCE) revolutionized relapsed refractory multiple myeloma (RRMM), non-Hodgkin lymphoma (NHL), and acute lymphoblastic leukemia (ALL) treatment. Immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) is a potentially fatal rare complication characterized by cytopenia, coagulopathy, transaminasemia, and hyperferritinemia. We aim to analyze the IEC-HS reported cases, patterns, and outcomes in RRMM and NHL patients undergoing CAR-T and TCE therapy utilizing the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database. We conducted a retrospective postmarketing pharmacovigilance inquiry using the FAERS database and the Medical Dictionary for Regulatory Activities (MEDRA). The database was accessed on March 20, 2025 to examine the adverse effects of CAR-T: idecabtagene vicleucel (ide-cel), ciltacabtagene autoleucel (cilta-cel), axicabtagene ciloleucel (axi-cel), brexucabtagene autoleucel (brexu-cel), tisagenlecleucel (tisa-cel) and lisocabtagene maraleucel (liso-cel), and TCE (teclistamab, elranatamab, talquetamab, mosunetuzumab, glofitamab, and epcoritamab) since their FDA approval in the United States and non-US populations. Descriptive analysis was used to describe reported proportions and outcomes. Reported mortality per product was calculated for patients with IEC-HS. Cases reported in 2024, were used to calculate reporting odds ratio (ROR) and empirical Bayesian geometric mean (EBGM) to compare the drugs for IECHS events reported. A total of 23,315 unique case safety reports (ICSRs) were analyzed, identifying 378 (1.62%) reports of IEC-HS. Reported mortality was high among these patients (n = 232/378, 61.3%). A formal disproportionality analysis, limited to 2024 reports to ensure a contemporary comparison, was performed. Tisa-cel (ROR 2.20) and cilta-cel (ROR 2.24) both demonstrated statistically significant disproportionate reporting signals for IEC-HS. In contrast, axi-cel, which accounted for the highest absolute number of reports (n = 114/378), did not show a significant signal in this analysis (ROR 1.02), suggesting its high case volume is proportional to its high overall reporting frequency. Teclistamab showed a significantly reduced likelihood of HLH reporting (ROR 0.43). IEC-HS is a rare but potentially fatal complication. Our disproportionality analysis identifies significant reporting signals for tisa-cel and cilta-cel. The high absolute number of cases observed for products like axi-cel appears to reflect high utilization rather than a disproportionate risk, underscoring the necessity of using statistical signal detection methods when interpreting spontaneous reports.

24 Feb 2026·Blood Advances

Brute force: the effects of ibrutinib on brexu-cel

Article

Author: Peterson, Chelsea E. ; Betts, Brian C.

24 Feb 2026·Blood Advances

Ibrutinib exposure correlates with improved efficacy of CAR T cells in patients with mantle cell lymphoma

Article

Author: Scarfò, Irene ; Huang, Tarinee ; Gallagher, Kathleen M. E. ; Leick, Mark B. ; Bozym, David J. ; Maus, Marcela V. ; Berger, Trisha R. ; Darnell, Eli P. ; Kanska, Justyna ; Balderrama-Gutierrez, Gabriela ; Budka, Justin ; Shen, Rhine

Abstract:

The pivotal ZUMA-2 trial evaluated the chimeric antigen receptor (CAR) T-cell therapy brexucabtagene autoleucel (brexu-cel) for the treatment of relapsed/refractory (R/R) mantle cell lymphoma (MCL), and ultimately led to the approval of brexu-cel for R/R MCL. Here we report a retrospective analysis of data and samples from ZUMA-2, analyzed by exposure to class of Bruton tyrosine kinase inhibitor (BTKi; first-generation ibrutinib vs second-generation acalabrutinib) in a treatment line before brexu-cel. We found that the ibrutinib-exposed group had significantly greater duration of progression-free survival, greater CAR T-cell expansion, and more CAR T-cell–related toxicity than the acalabrutinib-exposed group. Brexu-cel products from the ibrutinib-treated patients had increased frequencies of T helper 17 cells and transcriptional signatures associated with cytotoxic function. Seven days after infusion, peripheral blood CAR T cells from ibrutinib-exposed patients showed more pronounced effector memory differentiation, which independently correlated to clinical response to brexu-cel. In contrast, brexu-cel products from acalabrutinib-treated patients were enriched for central memory phenotypes and less effector differentiated at day 7 after infusion. Our findings revealed CAR T-cell phenotypic associations with previous BTKi use, and highlight BTKi exposure as a potentially important clinical variable in ZUMA-2 worthy of further study in efforts to improve CAR T-cell therapies. This trial was registered at www.ClinicalTrials.gov as NCT02601313.

244

News (Medical) associated with Brexucabtagene Autoleucel

24 Mar 2026

·www.prnewswire.com

Fosun Pharma Announces 2025 Annual Results

Innovation and Globalization Propel Fosun Pharma's High-Quality Growth SHANGHAI, March 24, 2026 /PRNewswire/ -- On 24 March, 2026, Fosun Pharma ("the company", stock code: 600196.SH; 02196.HK), an innovation-driven global pharmaceutical and healthcare group, announced its 2025 annual operating results (the reporting period). Powered by the dual engines of innovation and globalization, Fosun Pharma achieved total operating revenue of RMB 41.662 billion, up 1.45% year-on-year. Of this, revenue from innovative drugs reached RMB 9.893 billion, rising 29.59% year-on-year; overseas revenue amounted to RMB 12.977 billion, growing 14.87% year-on-year. Net profit attributable to shareholders of the parent company was RMB 3.371 billion, up 21.69% year-on-year; recurring net profit attributable to shareholders of the parent company amounted to RMB 2.34 billion, increasing 1.12% year-on-year; and net cash flow generated from operating activities reached RMB 5.213 billion, up 16.45% year-on-year, further consolidating the foundation for high-quality development. Innovative Drugs Emerge as Core Growth Engine Revenue from innovative drugs hit RMB 9.893 billion, accounting for 33.16% of pharmaceutical business revenue, becoming the core engine of performance growth. Total R&D investment for the year amounted to RMB 5.913 billion, up 6.46% year-on-year, of which R&D investment related to innovative pharmaceuticals reached RMB 4.303 billion, a year-on-year increase of 15.98%, accounting for 80.26% of pharmaceutical business R&D investment. High-intensity R&D investment has been translated into fruitful results. During the reporting period, 16 indications of 7 innovative drugs were approved for marketing in China and overseas markets; marketing applications for 6 innovative drug candidates were accepted, and nearly 40 innovative drug clinical trials received approval from China and overseas regulatory authorities; and multiple core products entered key clinical phases, laying a solid pipeline foundation for subsequent commercial growth. Additionally, 5 new innovative drugs were included in the 2025 National Reimbursement Drug List (NRDL), and the CAR-T therapy Yikaida (axicabtagene ciloleucel injection) was successfully listed in the first edition of the Commercial Insurance Innovative Drug Catalog. This not only improves patient access to innovative drugs but also further unlocks the volume potential of commercialization. Building Differentiated Clinical Pipeline Advantages Fosun Pharma focuses on innovative drugs as its development priority. Centering on the three core therapeutic areas of oncology (solid tumors, hematologic tumors), immune inflammation and neurodegenerative diseases, the Company continuously strengthens its pipeline construction through in-house R&D, collaborative development and licensing-in. Oncology: In 2025, Fosun Pharma further strengthened the layout of its innovative pipeline around key indications such as breast cancer and lung cancer. The company's self-developed small-molecule innovative drug Fumaining® (luvometinib Tablet) received approval for two indications, filling the gap in the treatment of rare tumors in China; the innovative small-molecule CDK4/6 inhibitor Futuoning® (fovinaciclib citrate capsules) was launched for two indications in China, bringing a brand-new treatment option for breast cancer patients; the anti-PD-1 monoclonal antibody Serplulimab Injection was approved in Europe and multiple emerging markets for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC), becoming the first anti-PD-1 monoclonal antibody to receive such approval in the EU and accelerating the company's globalization pace; antibody and ADC drugs such as HLX43 and HLX22 entered key clinical phases, continuously improving the echelon of the oncology pipeline. The marketing application for the second CAR-T product Brexucabtagene Autoleucel was accepted. Immune Inflammation and Chronic Diseases: The licensed-in first-in-class innovative drug Wantile (Tenapanor Hydrochloride Tablets) was successfully approved, providing a new treatment option for chronic kidney disease patients on dialysis in China. Steady clinical progress was made for core products such as FXS7553. Neurodegenerative diseases: Opicapone Capsules, a treatment for Parkinson's disease, was launched in the Boao Pilot Zone for innovative drugs. Fosun Insightech accelerated product upgrading and indication expansion for its Magnetic Resonance-guided Focused Ultrasound (MRgFUS) system. Sodium Oligomannate Capsule was incorporated into the Company's Alzheimer's disease innovative drug pipeline, with post-marketing confirmatory clinical trials underway. AR1001, an in-licensed asset, has advanced into global multi-center Phase 3 clinical trials. These initiatives further enriched the Company's product pipeline in the neurodegenerative disease sector. Breakthroughs in Cutting-Edge Technologies and Two-way Licensing On the basis of consolidating core technology platforms including antibodies, ADCs, small molecules, and cell therapy, Fosun Pharma is strategically investing in advanced fields such as radiopharmaceuticals and small interfering RNA (siRNA). The radiopharmaceutical project SRT-007 successfully initiated Phase I clinical trials, establishing a preliminary "imaging diagnosis - targeted therapy" integrated R&D pathway; in cell therapy, the autologous dual-target CAR-T product FKC289 had its clinical trial application accepted by the NMPA, continuously empowering the reserve of follow-on innovative products. In 2025, Fosun Pharma's global resource integration capability has been significantly enhanced. The total upfront payment from out-licensing reached over US$260 million in the whole year, with potential milestone payments exceeding US$ 3.8 billion. Among them, the global licensing project of the GLP-1 target YP05002 garnered an upfront payment of US$150 million and potential total payments of US$2.085 billion, fully confirming the global competitiveness of the company's innovative R&D. In terms of collaborative development, Fosun Pharma entered into a joint development agreement with Teva for FXB0871 and established original innovation cooperation with a fund under Aditum Bio. Meanwhile, Fosun Pharma introduced multiple overseas original drugs, including Akynzeo (netupitant and palonosetron hydrochloride capsules), Pu Rui Ni (pretomanid tablets) , and Daxxify (botulinum toxin type A for injection), through licensing-in, achieving marketing approval for them in China. Globalization Moves Towards "System-centric Globalization" In 2025, Fosun Pharma's international development achieved a strategic upgrade from "product-centric going global" to "system-centric globalization", making comprehensive breakthroughs in innovative R&D, production quality, registration and access, commercialization and academic influence, and building a global operation network covering markets such as China, the United States, Europe, Africa, India and Southeast Asia. In 2025, the company's overseas revenue reached RMB 12.977 billion, accounting for 31.15% of the total revenue, increased by 3.64 percentage points year-on-year. Fosun Pharma has built a global R&D and production synergy registration capability featuring "leading breakthroughs in Europe and the US, and in-depth cultivation in emerging markets". The core innovative drug Serplulimab Injection has been approved for marketing in more than 40 countries and regions worldwide. In the United States, the bridging study for first-line ES-SCLC has completed enrolment, with a Biologics License Application (BLA) submission planned for 2026. Biosimilars such as Denosumab have successively obtained approvals from the FDA and the EU, marking that the quality system and registration capability of the biologic drug platform have been certified to international standards; the small-molecule innovative drug Fumaining® received Priority Review status from the Saudi Food and Drug Authority (SFDA) in Saudi Arabia, becoming an important fulcrum to leverage the Middle East and global markets. Seventeen of Fosun Pharma's workshops/production lines in China have passed GMP certifications of mainstream regulatory markets such as the US, the EU and the WHO. The relevant biologic drug production lines have realized regular supply to the global market, covering China, Europe, Latin America, Southeast Asia, India and other markets. Multiple injection production lines of India's Gland Pharma have passed certifications in Europe, the US, Japan and Australia, providing a solid guarantee for the stability and quality controllability of the global supply chain. Fosun Pharma has formed a mature overseas go-global model of "independent operation + licensing authorization" running in parallel, with over 6,000 commercial personnel worldwide and established a marketing network covering over 40 countries and regions in Africa; the controlling subsidiary Sisram's marketing network covers over 110 countries and regions, while Breas covers over 50 countries and regions. ESG Governance Recognized by Global Authorities While achieving high-quality development of its core business, in 2025, Fosun Pharma's MSCI ESG rates were upgraded to "AA", retained its Hang Seng ESG rating of "A-" and was selected into the 2025 Fortune China ESG Influence List, being the only Chinese pharmaceutical enterprise on the list. "In 2025, Fosun Pharma firmly implemented its corporate strategy of Innovation Driven, Deep Globalization and AI Embracement, achieving high-quality growth powered by innovative drugs and globalization." Chen Yuqing, Chairman of Fosun Pharma said, "Looking ahead, Fosun Pharma will always focus on unmet clinical needs, continue to innovate, and further deepen its layout in core therapeutic areas such as oncology, immune inflammation and neurodegenerative diseases. It will integrate innovative resources from a global perspective, drive operational upgrading with digital intelligence, and strive to become a world-leading integrator of medical innovation, creating long-term value for shareholders and providing more high-quality and accessible medicines and healthcare solutions for patients." About Fosun Pharma Founded in 1994, Fosun Pharma (stock code: 600196.SH; 02196.HK) is an innovation-driven global pharmaceutical and healthcare group. With the mission of Better Health for Families Worldwide, we focus on developing innovative medicines, medical technologies and diagnostics as well as delivering healthcare services. Through our business partner Sinopharm Group, we have also established pharmaceutical distribution network, built a comprehensive pharmaceutical and healthcare ecosystem. Fosun Pharma is dedicated to innovation and globalization. The company has established a global R&D innovation system targeting at unmet medical needs. Our strategic focus is on key therapeutic areas including oncology, immunology and inflammation, neurodegenerative diseases, and selected cardiometabolic diseases and rare diseases. This approach enables the development of high valued competitive pipelines and comprehensive healthcare solutions. Meanwhile, Fosun Pharma has consolidated its core technical platforms including but not limited to antibodies and antibody-drug conjugates (ADC), small molecules and cell therapy. Additionally, we also actively advance cutting-edge therapeutic modalities such as radiopharmaceuticals and small nucleic acids. These efforts have strengthened our early-stage innovative portfolios and accelerated the transformation of scientific discoveries to drug development. Our innovative products are now available in more than 90 countries and regions worldwide, including major markets across China, the United States, Europe, Africa, India and Southeast Asia. Looking ahead, guided by the strategy of "Innovation Driven, Deep Globalization, and AI Embracement", Fosun Pharma remains committed to its core values: Care for life, Continuous innovation, Pursuit of excellence and Sustainable partnership. We strive to become a leading global healthcare innovation integrator, ensuring that the benefits of medical innovation reach more patients worldwide, and contribute to safeguarding human health. For more information, please visit the company website: SOURCE Fosun Pharma 21% more press release views with Request a Demo

Phase 1Drug ApprovalLicense out/in

24 Mar 2026

·www.fiercebiotech.com

Gilead\'s $2.2B Ouro buyout delivers autoimmune T-cell engager, new purpose for Galapagos

Gilead Sciences\' chief medical officer said the deal “underscores our commitment to ... serious autoimmune diseases.” \n Gilead Sciences is paying $1.67 billion for a T-cell engager (TCE) company via a front-loaded deal that could also give new meaning to its partner Galapagos.By acquiring GSK-founded Ouro Medicines, Gilead will get its hands on OM336, also known as gamgertamig, a BCMAxCD3 TCE aimed at autoimmune disorders. Ouro has taken OM336 into phase 1/2 studies, which have “demonstrated transformative efficacy and a differentiated safety profile” in conditions like autoimmune hemolytic anemia and immune thrombocytopenia—which both involve the autoimmune destruction of circulating blood cells—after a single treatment cycle, the pharma explained.As well as the $1.675 billion in upfront cash, Gilead has pledged up to $500 million in potential milestone payments for Ouro. The front-loaded nature of the deal means Gilead is handing over a lot of money before OM336 has even proven its worth in a phase 2 test. But the pharma has a plan—to rope in its partner Galapagos to pay half of the upfront and milestone payments.Galapagos’ retreat from cell therapy last year had left the company without a purpose. But CEO Henry Gosebruch explained to Fierce Biotech in November that Gilead—which owns 25% of Galapagos—expected the Belgian biopharma to continue to seek new assets to rebuild the company.Now, Galapagos could have a meaning once again. Gilead said yesterday that it is in advanced discussions for Galapagos to absorb “substantially all of Ouro Medicines’ operating assets and retain its employees.”Under these terms, Galapagos would be responsible for developing OM336 through to the launch of registrational studies, which Gilead hopes to start in 2027. Gilead will retain worldwide commercialization rights—except in China, where Keymed Biosciences already has the license.If OM336 makes it to market, Gilead would pay Galapagos royalties of between 20% and 23% of net sales.The Ouro buyout comes a month after Gilead went big for another cell therapy company, striking a $7.8 billion deal for Arcellx in February. That acquisition brought Gilead full control of anitocabtagene autoleucel, a BCMA-directed CAR-T on the cusp of approval as a direct challenger to Johnson & Johnson and Legend Biotech’s multiple myeloma blockbuster Carvykti.Gilead acquired cell therapy operations through its $11.9 billion Kite Pharma takeover in 2017 and already sells the CD19-directed treatments Tecartus and Yescarta. But the unit has struggled, with Gilead’s cell therapy sales falling 7% to $1.8 billion last year. BMO Capital Markets analysts said in a recent note to investors that the launch of anitocabtagene autoleucel could help Gilead’s cell therapy unit “regain its footing.” What sets yesterday’s deal apart is that Ouro’s TCE is being specifically targeted at autoimmune diseases—a hot area of cell therapy development.Gilead Chief Medical Officer Dietmar Berger, M.D., Ph.D., said buying Ouro “underscores our commitment to advancing transformative therapies for people living with serious autoimmune diseases.”“BCMA is a validated target with emerging data demonstrating potentially transformative outcomes in autoimmune diseases,” Dietmer said. “BCMA targeted T-cell engagers represent a differentiated approach with the potential to induce durable disease control.”“This novel framework complements our expanding inflammation pipeline and reflects our strategy to invest in innovative science that may redefine standards of care,” he added.Galapagos’ CEO Gosebruch also celebrated the chance for “meaningful flexibility in our relationship with Gilead.”“As Galapagos established a relationship with Ouro this past year, we have been impressed with the emerging clinical profile of gamgertamig, its clinically de-risked lead program, and the capability of the Ouro team,” Gosebruch said in a statement. “This is an exciting day in the transformation of Galapagos.”Ouro was launched by GSK and Monograph Capital in January 2025. The biotech arrived on the scene with $120 million in funds and the rights to OM336, which it licensed from China’s Keymed.Ouro’s CEO Jaideep Dudani, Ph.D., a portfolio principal at Monograph, explained at the time that the company’s conviction in OM336 stemmed from the successful off-label use of BCMA-directed TCEs in treating B-cell-mediated diseases.

Cell TherapyAcquisitionPhase 2License out/inImmunotherapy

25 Feb 2026

·www.fiercebiotech.com

Gilead inks $7.8B Arcellx buyout to steer CAR-T into J&J showdown

Gilead Sciences has struck a deal to buy Arcellx for $7.8 billion to take full control of a CAR-T cell therapy that is on the cusp of approval. Arcellx partnered with Gilead to develop the BCMA-directed CAR-T anitocabtagene autoleucel (anito-cel) in 2022. Gilead invested in Arcellx as part of the agreement and, having invested again when amending the deal in 2023, owns 11.5% of the company. With Gilead on the hook for $530 million in milestones for anito-cel, analysts had speculated about a potential buyout. Gilead made its move Monday, agreeing to pay $115 per share in cash for Arcellx. The offer represents a 68% premium to Arcellx’s 30-day volume-weighted average share price. Arcellx shareholders will receive another $5 per share if cumulative global anito-cel sales hit $6 billion by the end of 2029. Gilead CEO Daniel O’Day discussed the buyout in a statement. “This agreement reflects our conviction in the potential of anito-cel and our intention to move with speed so we can make the most of that potential for patients with multiple myeloma,” O’Day said. “Beyond the potential launch this year, anito-cel could become a foundational treatment for multiple myeloma over time, including earlier lines of therapy.” The FDA is reviewing a filing for approval of anito-cel as a fourth-line treatment for relapsed or refractory multiple myeloma. Gilead applied for priority review, but the Dec. 23 PDUFA date suggests the FDA will assess the filing under its standard pathway. The FDA approved Johnson & Johnson and Legend Biotech’s BCMA-directed CAR-T cell therapy Carvykti in 2022, and it's since attained blockbuster status. But, after speaking to physicians treating multiple myeloma patients, Guggenheim Securities analysts recently said in a note to investors that anito-cel is preferred to the incumbent. The preference reflects the therapies’ safety profiles. Gilead acquired cell therapy operations through its $11.9 billion Kite Pharma takeover in 2017 and sells the CD19-directed treatments Tecartus and Yescarta. The unit has struggled, though, with Gilead’s cell therapy sales falling 7% to $1.8 billion last year. BMO Capital Markets analysts said in a recent note to investors that the anito-cel launch could help Gilead’s cell therapy unit “regain its footing.” Analysts with William Blair viewed the deal terms “favorably,” citing the offer's premium on Arcellx's share price and the strong likelihood that Arcellx will collect the contingent value right tied to anito-cel, according to a Feb. 23 note. The analysts also believe Gilead saw long-term value in Arcellx’s other platforms, as demonstrated in the acquisition premium. The content above comes from the network. if any infringement, please contact us to modify.

Cell TherapyAcquisitionImmunotherapyPriority ReviewDrug 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
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
Hairy Cell Leukemia	Phase 2	France	Kite Pharma, Inc.	01 Nov 2022
Hairy Cell Leukemia	Phase 2	Germany	Kite Pharma, Inc.	01 Nov 2022
Hairy Cell Leukemia	Phase 2	Italy	Kite Pharma, Inc.	01 Nov 2022
Hairy Cell Leukemia	Phase 2	Netherlands	Kite Pharma, Inc.	01 Nov 2022
Hairy Cell Leukemia	Phase 2	Spain	Kite Pharma, Inc.	01 Nov 2022
Hairy Cell Leukemia	Phase 2	Switzerland	Kite Pharma, Inc.	01 Nov 2022
Recurrent Transformed Chronic Lymphocytic Leukemia	Phase 2	United States	Kite Pharma, Inc.	01 Nov 2022
Recurrent Transformed Chronic Lymphocytic Leukemia	Phase 2	Austria	Kite Pharma, Inc.	01 Nov 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05537766 (ZUMA-25, CTgov)	Phase 2	Hairy Cell Leukemia \| Burkitt Lymphoma \| Waldenstrom's macroglobulinaemia refractory ... View more	19	Fludarabine+Cyclophosphamide+Brexucabtagene Autoleucel (Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel)	mfbynsmepo = qhbdllprov abaondvars (uxquauhpku, esmxokqyxd - wwgppmcqcu)	-	10 Mar 2026
NCT05537766 (ZUMA-25, CTgov)	Phase 2		19	Fludarabine+Cyclophosphamide+Brexucabtagene Autoleucel (Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel)	yxjkzrruwj(ovodgfjvdx) = mmemjeibqp ncdurpxfro (mgearenbjj, ocfhldnllu - vsfzfjrlak) View more	-	10 Mar 2026
Tandem Meetings ASTCT and CIBMTR2026	Not Applicable	Refractory B Acute Lymphoblastic Leukemia	8	Brexucabtagene Autoleucel (Brexu-cel)	qajqwnhupo(ukxgqpgwmg) = prfcjosnmn wenazetniv (xxrgfvssqv ) View more	Positive	04 Feb 2026
Tandem Meetings ASTCT and CIBMTR2026	Not Applicable	B-Cell Lymphoma	235	Axicabtagene ciloleucel (Yescarta)	uknpgubjpd(prtwlgajtb) = nftzjvvelg kamejzjwov (pkjliwjejw, 14.2 - 14.61) View more	Positive	04 Feb 2026
Tandem Meetings ASTCT and CIBMTR2026	Not Applicable	B-Cell Lymphoma	235	Brexucabtagene autoleucel (Tecartus)	uknpgubjpd(prtwlgajtb) = neeqkyvlkr kamejzjwov (pkjliwjejw, 14.79 - 16.46) View more	Positive	04 Feb 2026
Tandem Meetings ASTCT and CIBMTR2026	Not Applicable	Hematologic Neoplasms	10	CAR-T	vxcculuyhq(ushmgxfwqw) = msnwgyvczp qharzktydy (tdpnpuszpl ) View more	Positive	04 Feb 2026
NCT03642626 (MT2017-45, CTgov)	Phase 2	Philadelphia positive acute lymphocytic leukaemia \| Large B-cell lymphoma \| Acute Lymphoblastic Leukemia ... View more	150	YESCARTA+Fludarabine+Cyclophosphamide (ARM B: Yescarta for Refractory Diffuse Large B Cell Lymphoma (DLBCL))	zsrdtbrfep = wsiufywdkx pecftynymg (owvalusxiw, vcjywxqgad - puhvqvaeno) View more	-	23 Jan 2026
NCT03642626 (MT2017-45, CTgov)	Phase 2		150	Fludarabine+Cyclophosphamide+KYMRIAH (ARM C: Kymriah for Refractory Diffuse Large B Cell Lymphoma (DLBCL))	zsrdtbrfep = ojjttiztny pecftynymg (owvalusxiw, vxzuyvhlmk - gxeikazbwc) View more	-	23 Jan 2026
ChiCTR2300073872 (ASH2025) Manual	Phase 2	Precursor B-Cell Lymphoblastic Leukemia-Lymphoma	28	KTE-X19	djdqkrinby(qikeuimjis) = xivnafiiuy ntciujzwku (mtenghseat, 62.0 - 90.2) View more	Positive	06 Dec 2025
NCT05495464 (WINDOW-3, ASH2025)	Phase 1	Mantle-Cell Lymphoma First line	20	Acalabrutinib plus rituximab	xbudumzphx(apehxdwmds) = only one patient had grade 3 adverse event (AE, skin rash) zwvsziqapw (pflesiayvc ) View more	Positive	06 Dec 2025
NCT04880434 (ZUMA-2 Cohort 3, ASH2025)	Phase 2	Mantle cell lymphoma refractory	86	Brexucabtagene autoleucel (Brexu-cel)	iojvtpsegc(ukdmttvplj) = rvujjswjqj rcuxmsqhqt (tnvzmlysfr, 82.5 - 95.9) View more	Positive	06 Dec 2025
ASH2025	Not Applicable	Acute lymphoblastic leukemia recurrent	92	Obecabtagene autoleucel (obe-cel)	oqsgkcmfjf(wvsbhbbcmg) = ibbibpxsql qnidncioqt (ounsaoruzy ) View more	Positive	06 Dec 2025
ASH2025	Not Applicable	Acute lymphoblastic leukemia recurrent	92	Brexucabtagene autoleucel (brexu-cel)	oqsgkcmfjf(jhteugcuet) = rkcfgjydvx fqfiocgawx (rbwqssrfns ) View more	Positive	06 Dec 2025
NCT05537766 (ZUMA-25, ASH2025)	Phase 2	Burkitt Lymphoma	10	Brexucabtagene autoleucel (brexu-cel)	qxlyjjzimc(gyjpyfknjw) = dxjzblfazs zjginegrti (hrrhqwovgi, 69 - 100) View more	Positive	06 Dec 2025

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