RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Orphan Drug (South Korea), Regenerative Medicine Advanced Therapy (United States), Conditional marketing approval (China)

Structure/Sequence

Sequence Code 9718ScFv

Sequence Code 170963ScFv

Sequence Code 13042446CAR construct

Clinical Trials associated with Axicabtagene Ciloleucel

NCT06902012

/ RecruitingPhase 1/2IIT

A Prospective, Single - Arm Clinical Study on the Safety and Efficacy of Early Second Infusion of CD19 CAR - T Based on ctDNA Monitoring in the Treatment of Relapsed/Refractory Large B - Cell Lymphoma

The goal of this clinical trial is to evaluate the efficacy and safety of early secondary infusion of CD19 CAR T-cell therapy in adults with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), guided by ctDNA monitoring. The main questions it aims to answer are:
1. Efficacy: Does early secondary CAR-T infusion improve the 3-month complete remission (CR) rate and long-term survival outcomes (e.g., 1-year PFS, OS)?
2. Safety: What are the adverse events associated with secondary CAR-T infusion, such as cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity (ICANS), and infections?
This is a single-arm, single-center, prospective study. All participants will receive:
* Leukapheresis to collect T cells for CAR-T manufacturing.
* Preconditioning chemotherapy (fludarabine and cyclophosphamide) to prepare the body for CAR-T infusion.
* Two CD19 CAR-T infusions: The first infusion (2×10⁶ cells/kg) followed by a second infusion (same dose) if ctDNA remains positive when PET/CT shows CR or PET/CT shows PR within 60 days post-first infusion.
Participants will undergo:
* Frequent hospital monitoring for ≥14 days post-infusion to manage potential toxicities.
* Regular follow-ups (e.g., blood tests, ctDNA analysis, PET/CT scans) at scheduled intervals up to 12 months.
* Continuous safety assessments, including CRS grading, neurological evaluations, and infection monitoring.

Start Date01 Feb 2027

Sponsor / Collaborator-

NCT07042438

/ Not yet recruitingPhase 2IIT

A Phase 2 Randomized Trial of Remodeling Intestinal Microbiota Using Fecal Microbiome Transplant (FMT) Among Recipients of Chimeric Antigen Receptor T Cells (CAR T)

This phase II trial tests how well fecal microbiome transplantation works to remodel intestinal microbiota for patients with lymphoma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory) with exposure to high-risk antibiotics who are receiving chimeric antigen receptor (CAR) T cells. Fecal microbiome transplantation consists of fecal microbiota from healthy donors with healthy gut microbiota that allows re-population of the patient's microbiome with diverse protective microorganisms. CAR 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 (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Part of the treatment for CAR T therapy involves high doses of chemotherapy. This, along with prior exposure to high strength antibiotics, can damage patient's intestinal microbiota. Giving fecal microbiome transplantation may improve clinical response by repairing intestinal microbiota for patients with relapsed or refractory lymphoma who had exposure to high-risk antibiotics.

Start Date17 Jan 2026

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

ACTRN12625000673448

/ Not yet recruitingPhase 2IIT

Detection of Ultra-High Risk Large B-Cell Lymphoma for EarlyDelivery of Axicabtagene Ciloleucel: A therapeutic arm of theALLG NHL34 CLARIFY study

Start Date23 Oct 2025

Sponsor / Collaborator

Australasian Leukaemia & Lymphoma Group

100 Clinical Results associated with Axicabtagene Ciloleucel

100 Translational Medicine associated with Axicabtagene Ciloleucel

100 Patents (Medical) associated with Axicabtagene Ciloleucel

624

Literatures (Medical) associated with Axicabtagene Ciloleucel

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Budget impact of introducing glofitamab for treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy in the United States

Article

Author: Li, Jia ; Mahmoudjafari, Zahra ; Masaquel, Anthony ; Parisé, Hélène ; Bercaw, Eric ; Bognar, Katalin ; Wang, Si-Tien

BACKGROUND:

Glofitamab is a T-cell engaging bispecific monoclonal antibody that was granted accelerated approval from the United States Food and Drug Administration for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after ≥2 lines of systemic therapy (3L+).

METHODS:

A budget impact model was developed for a hypothetical blended commercial/Medicare health plan with 1,000,000 members. Comparators were axicabtagene ciloleucel (Axi-cel), lisocabtagene maraleucel (Liso-cel), tisagenlecleucel (Tisa-cel), loncastuximab tesirine, polatuzumab vedotin + bendamustine + rituximab, rituximab + gemcitabine + oxaliplatin, tafasitamab + lenalidomide, and epcoritamab (Epcor). Total costs included those for drugs, wastage, administration, grade ≥3 adverse reactions, and all-grade cytokine release syndrome) and routine care. Market shares were based on internal projections and expert opinions. Total and per-member per-month (PMPM) net budget impacts over 3 years were calculated.

RESULTS:

Approximately nine patients were projected to be eligible for 3L + DLBCL treatment in a health plan of 1,000,000 members. The introduction of glofitamab as a treatment option resulted in estimated total and PMPM cost savings of $728,697 and -$0.0202, respectively, over 3 years. Costs were reduced across all cost categories but particularly in drug costs. Among the newer therapies, total 3-year cost per treated patient was lowest for glofitamab: $226,658 versus Tisa-cel = $564,113; Axi-cel = $540,002; Liso-cel = $516,272; and Epcor = $335,293. Across all sensitivity analyses, the inclusion of glofitamab had minimal PMPM budget impact, ranging from -$0.0256 to -$0.0108.

CONCLUSIONS:

With the lowest 3-year total cost per treated patient among the newer therapies, glofitamab being an available option in the 3L + DLBCL market is estimated to save a hypothetical 1,000,000-member health plan $728,697 in cumulative total costs and $0.0202 in PMPM costs over 3 years.

02 Sep 2025·Future Oncology

Clinical representativeness of pivotal trials for T-cell engagers in relapsed/refractory follicular lymphoma

Article

Author: Rivas Navarro, Fernando ; Bains Chawla, Savreet ; Tybor, David ; Atiya, Mohammad ; Favaro, Elena ; Marques Goncalves, Felipe ; Zhang, Guihua ; Wang, Tongsheng ; Mutebi, Alex ; Ding, Zhijie ; Wang, Anthony ; Kamalakar, Rajesh ; Yu, Junhua ; Chhibber, Anindit ; Alshreef, Abualbishr

AIM:

To characterize trial populations of T-cell-engaging therapies, including bispecific antibodies and chimeric antigen receptor T-cell therapies, for relapsed/refractory (R/R) follicular lymphoma (FL) after ≥ 2 systemic therapies and the extent to which they represent real-world R/R FL populations.

METHODS:

Inclusion/exclusion criteria and baseline characteristics were compared descriptively for EPCORE NHL-1 (epcoritamab, N = 128), GO29781 (mosunetuzumab, N = 90), ELARA (tisagenlecleucel [tisa-cel], N = 97), and ZUMA-5 (axicabtagene ciloleucel [axi-cel], N = 124). Real-world data from the COTA Healthcare (New York, NY) and Optum Market Clarity (Eden Prairie, MN) databases contextualized the clinical representativeness of trial populations.

RESULTS:

The epcoritamab trial enrolled a higher proportion of patients who were older, had higher Follicular Lymphoma International Prognostic Index scores, and were more double-refractory versus other trials. Notably, 37% of epcoritamab trial patients would have been excluded from the mosunetuzumab trial, 30% from the tisa-cel trial, and 29% from the axi-cel trial. These excluded subgroups were characterized by factors associated with poor clinical outcomes.

CONCLUSION:

The epcoritamab trial enrolled more broadly and was more representative of typical R/R FL patients than the mosunetuzumab, tisa-cel, and axi-cel trials. Differences in patient characteristics should be considered when evaluating the comparative benefits of T-cell engagers in R/R FL after ≥ 2 systemic therapies.

01 Sep 2025·CURRENT OPINION IN ONCOLOGY

Chimeric antigen receptor T-cell therapy in aggressive lymphomas

Review

Author: Crochet, Gilles ; Bernard, Wivine ; André, Marc

Purpose of review:

This review provides the latest update on chimeric antigen receptor (CAR) T-cell therapy in diffuse large B-cell lymphoma (DLBCL), as of April 2025, with a focus on specific patient populations, long-term toxicities, and the optimal sequencing of therapies, particularly in view of emerging treatments such as bispecific antibodies.

Recent findings:

Currently, three autologous CAR T-cell therapies targeting CD19 (axicabtagene ciloleucel, tisagenlecleucel, and lisocabtagene maraleucel) have been approved for third-line treatment of DLBCL, demonstrating durable complete remission rates of up to 40%. More recently, axicabtagene ciloleucel and lisocabtagene maraleucel have been approved for second-line therapy in refractory or early-relapsed DLBCL. Additionally, the emergence of CD20/CD3 bispecific antibodies has expanded therapeutic options for relapsed/refractory DLBCL, raising questions about the optimal sequencing of these therapies. Growing real-world evidence further supports the efficacy of CAR T-cell therapy in specific populations, including elderly patients, patients with transformed indolent B-cell non-Hodgkin lymphoma, and those with Richter's transformation. Finally, extended follow-up periods have allowed for a better characterization of the long-term toxicities associated with CAR T-cell therapy.

Summary:

Recent data on CAR T-cell therapy in DLBCL provides valuable insights into its benefits for specific populations, the optimization of treatment sequencing, and the management of long-term toxicities.

445

News (Medical) associated with Axicabtagene Ciloleucel

03 Sep 2025

·www.globenewswire.com

Lyell Immunopharma Announces the Initiation of a Phase 3 Head-to-Head CAR T-Cell Therapy Clinical Trial in Aggressive Large B-Cell Lymphoma and Formation of Expert Steering Committee

PiNACLE - H2H will evaluate rondecabtagene autoleucel (ronde-cel) versus investigator’s choice of approved CD19 CAR T-cell therapies in patients with aggressive large B-cell lymphoma receiving treatment in the second line (2L) settingRonde-cel is Lyell’s next-generation, dual-targeting CD19/CD20 CAR T-cell therapy designed to deliver improved complete response rates and longer duration of responses over currently approved CD19 CAR T-cell therapiesSteering Committee of distinguished lymphoma experts established to advise on the design and conduct of this first-of-its-kind CAR T-cell clinical trial SOUTH SAN FRANCISCO, Calif., Sept. 03, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing next-generation CAR T-cell therapies for patients with cancer, today announced the initiation of PiNACLE - H2H, a Phase 3 head-to-head CAR T-cell therapy randomized controlled trial and the formation of a Steering Committee of preeminent lymphoma experts. The trial is evaluating rondecabtagene autoleucel (ronde-cel, also known as LYL314) compared to lisocabtagene maraleucel (liso-cel) or axicabtagene ciloleucel (axi-cel) for the treatment of patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) receiving treatment in the 2L setting. Ronde-cel is an autologous dual-targeting CD19/CD20 chimeric antigen receptor (CAR) T-cell product candidate with Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration (FDA) for development in patients with R/R LBCL. Ronde-cel targets B cells that express either CD19, CD20, or both, and is manufactured to produce a product with higher proportions of naïve and central memory T cells – features that are designed to deliver improved complete response rates and durability for patients. “We believe, based on the robust emerging clinical profile demonstrated by ronde-cel in the Phase 1/2 trial, that targeting both CD19 and CD20 with full potency can deliver more complete responses and prolong the duration of remission as compared to the single antigen-targeting CD19 CAR T-cell therapies currently approved for patients with aggressive large B-cell lymphoma,” said David Shook, MD, Lyell’s Chief Medical Officer. “We are delighted to be collaborating with a distinguished group of lymphoma and cell therapy experts on the design and conduct of our ground-breaking head-to-head clinical trial and expect to begin enrolling patients by early 2026.” “Lyell is undertaking a well-designed and innovative Phase 3 trial to provide patients and their physicians with the data needed to demonstrate the potential clinical benefit of ronde-cel, a dual-targeting CD19/CD20 CAR T-cell therapy, over and above that of the currently approved CD19 CAR T-cell therapies,” said Michael Jain, MD, PhD, PiNACLE - H2H Steering Committee member and Immune Cell Therapy Medical Director in the Moffitt Cancer Center Department of Blood and Marrow Transplant and Cellular Immunotherapy. “I am encouraged by the promising data from the Phase 1/2 clinical trial of ronde-cel and believe this innovative cell therapy can improve clinical outcomes for patients.” “Lyell is leading the field with the announcement of the first Phase 3 head-to-head CAR T-cell therapy trial for patients with large B-cell lymphoma,” said Matthew Lunning, DO, PiNACLE - H2H Steering Committee member and Professor in the Division of Hematology/Oncology at the University of Nebraska Medical Center. “We have designed this trial evaluating ronde-cel to include the spectrum of patients who are currently receiving CD19 CAR T-cell therapy in the large B-cell lymphoma setting, as well as to provide the option for treatment in the outpatient setting based on the safety profile observed to date.” Members of the PiNACLE - H2H Steering Committee include: Michael Bishop, MD, Professor of Medicine and Director, Hematology/Oncology Cellular Therapy Program, University of Chicago, Chicago, ILMichael Jain, MD, PhD, Immune Cell Therapy Medical Director in the Moffitt Cancer Center Department of Blood and Marrow Transplant and Cellular Immunotherapy, Tampa, FLManali Kamdar, MD, Associate Professor of Medicine and Hematology and Clinical Director of Lymphoma Services, University of Colorado, Denver, COMatthew Lunning, DO, Professor in the Division of Hematology/Oncology and Medical Director of Cellular Therapy at the University of Nebraska Medical Center, Omaha, NEKrish Patel, MD, Director of Lymphoma Research at Sarah Cannon Research Institute (SCRI), Nashville, TNJason Westin, MD, Professor, Department of Lymphoma/Myeloma, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX Lyell is advancing two pivotal trials for patients with R/R LBCL: PiNACLE - H2H is a Phase 3 head-to-head CAR T-cell therapy randomized controlled clinical trial of ronde-cel versus investigator’s choice of either liso-cel or axi-cel in patients with R/R LBCL receiving treatment in the 2L setting. Patients randomized to ronde-cel will be treated with a dose of 100 x 106 CAR T cells. The primary endpoint of the trial is event-free survival. The trial is expected to enroll approximately 400 patients with R/R LBCL, including diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, high grade B-cell lymphoma, grade 3B follicular lymphoma, or transformed follicular or transformed mantle cell lymphoma who have not previously received CAR T-cell therapy. Patients may be treated with ronde-cel in either the inpatient or outpatient setting and are required to remain near the treating center for 14 days. Clinical site initiation is underway in the United States and Australia, and the first patient is expected to be enrolled by early 2026.PiNACLE is a single-arm pivotal trial of ronde-cel that is enrolling patients with R/R LBCL receiving treatment in the third- or later-line (3L+) setting. This trial is a seamless expansion of the 3L+ cohort of the Phase 1/2 trial of ronde-cel and is expected to enroll approximately 120 patients. The primary endpoint is overall response rate. About Rondecabtagene Autoleucel (Ronde-cel) Rondecabtagene autoleucel (ronde-cel, also known as LYL314) is a next-generation dual-targeting CD19/CD20 CAR T-cell product candidate designed to increase complete response rates and prolong the duration of the responses as compared to the approved CD19‑targeted CAR T-cell therapies for the treatment of R/R LBCL. Ronde-cel is designed with an ‘OR’ logic gate to target B cells that express either CD19, CD20 or both, each with full potency. Ronde-cel is manufactured to produce a CAR T-cell product with higher proportions of naïve and central memory T cells through a proprietary process that enriches for CD62L-expressing cells. This manufacturing process is designed to generate CAR T cells with enhanced antitumor activity. Ronde-cel has received RMAT designation, as well as Fast Track Designation, from the FDA for the treatment of patients with R/R LBCL in the 3L+ setting. About Lyell Lyell is a late-stage clinical company advancing a pipeline of next-generation CAR T-cell therapies for patients with hematologic malignancies and solid tumors. To realize the potential of cell therapy for cancer, Lyell utilizes a suite of technologies to endow CAR T cells with attributes needed to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical responses, including the ability to resist exhaustion, maintain qualities of durable stemness, and function in the hostile tumor microenvironment. Lyell’s LyFE Manufacturing Center™ has commercial launch capability and can manufacture more than 1,200 CAR T-cell doses at full capacity. To learn more, please visit www.lyell.com. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: the potential clinical benefits and therapeutic potential of ronde-cel for patients with R/R LBCL, including its potential to increase complete response rates and prolong the duration of responses as compared to approved CD19-targeted CAR T-cell therapies for the treatment of LBCL; the potential benefits, if any, from the RMAT and Fast Track designations from the FDA for the treatment of patients with R/R LBCL in the 3L+ setting; statements made by our Chief Medical Officer and members of the PiNACLE – H2H Steering Committee; expectations around enrollment, trial design, dosing and timing of -PiNACLE and PiNACLE H2H; the sufficiency of the capacity of LyFE to manufacture drug supply for Lyell’s ongoing and planned pivotal trials and through potential commercial launch; and other statements that are not historical fact. These statements are based on Lyell’s current plans, objectives, estimates, expectations and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: the potential for results from clinical trials to differ from nonclinical, early clinical, preliminary or expected results; Lyell’s limited experience as a company in enrolling and conducting clinical trials and lack of experience in completing clinical trials; significant adverse events, toxicities or other undesirable side effects associated with Lyell’s product candidates; Lyell’s ability to initiate or progress clinical trials on the anticipated timelines, if at all; RMAT and Fast Track designations may not actually lead to faster development, regulatory review or approval process, and does not assure ultimate FDA approval; the significant uncertainty associated with Lyell’s product candidates ever receiving any regulatory approvals; Lyell’s ability to obtain, maintain or protect intellectual property rights related to its product candidates; the complexity of manufacturing cellular therapies and Lyell’s ability to manufacture and supply its product candidates for its clinical trials; implementation of Lyell’s strategic plans for its business and product candidates; the sufficiency of Lyell’s capital resources and need for additional capital to achieve its goals; the effects of macroeconomic conditions, including the effects of disruption between the U.S. and its trading partners due to tariffs or other policies, and any geopolitical instability; potential changes to U.S. drug pricing, including the potential for “most-favored nations” pricing limitations; and other risks, including general economic conditions and regulatory developments, not within our control; and other risks described under the heading “Risk Factors” in Lyell’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the Securities and Exchange Commission on August 12, 2025. Forward-looking statements contained in this press release are made as of this date, and Lyell undertakes no duty to update such information except as required under applicable law. Contact: Ellen Rose Senior Vice President, Communications and Investor Relations erose@lyell.com

Cell TherapyImmunotherapyPhase 3Fast Track

22 Aug 2025

·pharma.economictimes.indiatimes.com

Gilead unit to acquire cell therapy developer Interius for $350 million

Bengaluru: Gilead Sciences ' unit Kite Pharma said on Thursday it will acquire privately-held biotech firm Interius BioTherapeutics for $350 million in cash to advance CAR T-cell cancer therapies that are delivered directly into patients. WHY IT'S IMPORTANT The acquisition will enable Kite to use Interius' platform to deliver cell therapy directly into patients, simplifying treatment processes and reducing costs, the company said. BY THE NUMBERS Kite said the deal, expected to close pending regulatory approvals, will reduce Gilead's 2025 profit per share by about 23 cents to 25 cents. CONTEXT In CAR T-cell therapy , a patient's T-cells, a key part of the immune system, are modified to better recognize and attack cancer cells. Traditional CAR T-cell therapies, including Kite's approved blood cancer treatments Yescarta and Tecartus, involve taking immune cells from a patient. These are modified in a lab, and then put back into the patient's body - a process that is both complex and expensive. Interius' so-called "in-vivo" approach uses intravenous infusion to deliver DNA directly into cells, potentially accelerating and simplifying treatments, according to the Kite. Interest in in-vivo CAR T-cell platforms has surged, with over $2 billion invested and multiple partnerships formed recently, according to a report by clinical research firm Novotech. The report noted that more than five in-vivo CAR T-cell programs have entered clinical trials, and disclosed assets are expected to surpass 100 by the end of 2025. WHAT'S NEXT After the deal is approved, Interius' operations will merge with Kite's research team in Philadelphia, the Gilead unit added. (Reporting by Siddhi Mahatole in Bengaluru, additional reporting by Sneha S K; Editing by Leroy Leo)

Cell TherapyAcquisitionImmunotherapy

22 Aug 2025

·www.pharmaceutical-technology.com

Gilead’s Kite scoops in vivo CAR-T specialist Interius for $350m

Analysis by GlobalData indicates that in vivo CAR-T therapies sidestep many of the drawbacks seen in ex vivo counterparts. Credit: Michael Vi via Shutterstock.com. Gilead is soaring to new heights in the CAR-T therapeutics sector, acquiring in vivo cell therapy specialist Interius BioTherapeutics via its subsidiary Kite for $350m. The deal will integrate Interius’ in vivo platform into Kite’s existing cell therapy framework, along with the uniting of research teams. The end goal is to generate CAR T-cells directly within the patient’s body, an approach that may “offer a more durable and long-lasting therapeutic effect”, according to Kite. Gilead acquired Kite for $11.9bn in 2017, and it operates as the big pharma’s cell therapy subsidiary. By inserting DNA into a patient’s genome, unlike traditional CAR-T approaches in which cells are infused back into the blood, Interius aims to deliver therapy via a single intravenous infusion. Kite said that this has the added benefit of eliminating the need for preconditioning chemotherapy and complex cell processing. Gilead is eying the technology to improve upon its two US Food and Drug Administration (FDA) approved CAR-Ts for types of blood cancer — Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel). These are traditional ex vivo therapies that require cell harvesting, engineering and reinfusion – the steps that Interius seeks to eliminate. “In vivo therapy is a promising frontier with the potential to transform how we approach treating patients, shifting to more accessible and scalable solutions,” said Cindy Perettie, Kite’s executive vice-president. 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 Analysis by GlobalData indicates that in vivo CAR-T therapies sidestep many of the drawbacks seen in ex vivo counterparts. Though warns that one concern is the inability to quality check before dosing, adding that more clinical data is needed to demonstrate safety. Gilead is not the only big pharma company enticed by CAR-T-centric acquisitions so far this year. AbbVie bought CAR-T developer Capstan Therapeutics for $2.1bn in July while AstraZeneca spent $425m to acquire Belgium-based EsoBiotec in March. The deal for AstraZeneca comes a year and a half after it acquired Chinese CAR-T biotech Gracell for $1.2bn in December 2023. For Interius, the deal marks a successful validation of its clinical activities. It was the first biotech to progress an in vivo CAR-T therapy into clinical trials. Its B-cell malignancy treatment candidate, called INT2104, entered a Phase I trial (NCT06539338) in October 2024. Despite being armed with Interius’ innovative platform, Kite will have to navigate a currently volatile cell and gene sector in the US. Vinay Prasad, director at the FDA’s Center for Biologics Evaluation and Research (CBER) – the department responsible for regulating cell and gene therapies, stepped down from his role in July only to return to his job two weeks later. Prasad has been against the use of surrogate endpoints as evidence for accelerated approvals in the cell and gene therapy sector, leading to uncertainty in the field for biotechs using this approach in clinical trials. Surrogate endpoints, such as overall response rate (ORR) and progression-free survival (PFS), are frequently used in CAR-T therapy trials to accelerate evaluation. 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 Whitepaper Cell and gene therapies: Pipe dream to pipeline The cell and gene industry is gaining momentum, with a new wave of therapies promising to transform the way doctors treat, and even cure, disease. In this report, Cytiva and GlobalData have collaborated to explore the rise of the cell and gene therapy industries, the current state of the market, present and future opportunities for advancement, and the challenges that lie ahead. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. 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 TherapyAcquisitionPhase 1Immunotherapy

100 Deals associated with Axicabtagene Ciloleucel

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01	DB13915

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Primary mediastinal large B-cell lymphoma refractory	South Korea	Gilead Sciences Korea Ltd.	13 Aug 2025
High grade B-cell lymphoma	Canada	Gilead Sciences Canada, Inc.	13 Feb 2019
Diffuse Large B-Cell Lymphoma	European Union	Kite Pharma EU BV	23 Aug 2018
Diffuse Large B-Cell Lymphoma	Iceland	Kite Pharma EU BV	23 Aug 2018
Diffuse Large B-Cell Lymphoma	Liechtenstein	Kite Pharma EU BV	23 Aug 2018
Diffuse Large B-Cell Lymphoma	Norway	Kite Pharma EU BV	23 Aug 2018
Mediastinal large B-cell lymphoma	European Union	Kite Pharma EU BV	23 Aug 2018
Mediastinal large B-cell lymphoma	Iceland	Kite Pharma EU BV	23 Aug 2018
Mediastinal large B-cell lymphoma	Liechtenstein	Kite Pharma EU BV	23 Aug 2018
Mediastinal large B-cell lymphoma	Norway	Kite Pharma EU BV	23 Aug 2018
Recurrent Follicular Lymphoma	European Union	Kite Pharma EU BV	23 Aug 2018
Recurrent Follicular Lymphoma	Iceland	Kite Pharma EU BV	23 Aug 2018
Recurrent Follicular Lymphoma	Liechtenstein	Kite Pharma EU BV	23 Aug 2018
Recurrent Follicular Lymphoma	Norway	Kite Pharma EU BV	23 Aug 2018
Refractory Follicular Lymphoma	European Union	Kite Pharma EU BV	23 Aug 2018
Refractory Follicular Lymphoma	Iceland	Kite Pharma EU BV	23 Aug 2018
Refractory Follicular Lymphoma	Liechtenstein	Kite Pharma EU BV	23 Aug 2018
Refractory Follicular Lymphoma	Norway	Kite Pharma EU BV	23 Aug 2018
Follicular Lymphoma	United States	Kite Pharma, Inc.	18 Oct 2017
Large B-cell lymphoma	United States	Kite Pharma, Inc.	18 Oct 2017

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	United States	Kite Pharma, Inc.	25 Jan 2018
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	Australia	Kite Pharma, Inc.	25 Jan 2018
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	Austria	Kite Pharma, Inc.	25 Jan 2018
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	Belgium	Kite Pharma, Inc.	25 Jan 2018
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	Canada	Kite Pharma, Inc.	25 Jan 2018
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	France	Kite Pharma, Inc.	25 Jan 2018
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	Germany	Kite Pharma, Inc.	25 Jan 2018
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	Israel	Kite Pharma, Inc.	25 Jan 2018
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	Italy	Kite Pharma, Inc.	25 Jan 2018
T-cell/histiocyte rich large B-cell lymphoma	Phase 3	Netherlands	Kite Pharma, Inc.	25 Jan 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CIBMTR (NEWS \| Pubmed)	Not Applicable	Mediastinal large B-cell lymphoma	135	阿基仑赛	zikeoibgxx(klokntheig) = imniiqejts mmwczoaati (ginznbwsce ) View more	Positive	11 Aug 2025
CIBMTR (NEWS \| Pubmed)	Not Applicable	Mediastinal large B-cell lymphoma	135	阿基仑赛 (ICI暴露组)	phanjhprgx(aswsckejgg) = tqhdiohrly bouxxmrffi (nquwteejwv ) View more	Positive	11 Aug 2025
NCT03391466 (ZUMA-7, ASCO2025)	Phase 3	Large B-cell lymphoma circulating tumor DNA (ctDNA)	44	Axicabtagene ciloleucel (axi-cel)	dezmovlarr(syaftlqarm) = qdsvdsylnf tyifbzccqs (atkrsujvez )	Positive	30 May 2025
NCT03391466 (ZUMA-7, ASCO2025)	Phase 3	Large B-cell lymphoma circulating tumor DNA (ctDNA)	44	axicabtagene ciloleucel (Standard of care (SOC))	dezmovlarr(syaftlqarm) = hfoegvpbti tyifbzccqs (atkrsujvez )	Positive	30 May 2025
ASCO2025	Not Applicable	Secondary Central Nervous System Lymphoma CD19	65	Axicabtagene ciloleucel	pvbzfspmth(txxkujputz) = ltwtocoqyr xvnvfhmibp (ravuijdvtr, 51 - 77) View more	-	30 May 2025
NCT03391466 (ZUMA-7, EHA2025)	Phase 3	Large B-cell lymphoma ctDNA	44	Axicabtagene Ciloleucel (Axi-Cel)	dxlkfydtzk(wmnpijrwpt) = qwisoqqmss zhyyywgfzq (meqpcbgojj ) View more	Positive	22 May 2025
NCT03391466 (ZUMA-7, EHA2025)	Phase 3	Large B-cell lymphoma ctDNA	44	AXICABTAGENE CILOLEUCEL (Standard of Care (SOC))	dxlkfydtzk(wmnpijrwpt) = uuqxebnfrm zhyyywgfzq (meqpcbgojj ) View more	Positive	22 May 2025
PS1922 (EHA2025)	Not Applicable	T-cell/histiocyte rich large B-cell lymphoma	33	CAR-T (Patients with T Cell Histiocyte-Rich Large B-Cell Lymphoma)	majlppzedr(ghhlxlwdpm) = mxyurklvam bjwpzwhkvn (pmudltwvnr ) View more	Negative	14 May 2025
EHA2025	Not Applicable	Lymphoma Second line	-	Axicabtagene ciloleucel (Axicel)	khofxirrjz(qqcaadzakk) = puznbwqnae fgsfdzwmyg (jrmtpjkkrr ) View more	-	14 May 2025
NCT04150913 (CTgov)	Phase 2	Non-Hodgkin's lymphoma refractory \| Recurrent Non-Hodgkin Lymphoma	15	Anakinra+Axicabtagene Ciloleucel	etxzyunlbb = bfhwibmivh ilnylcwcub (piilzwtayk, obqxbznnel - vmvokpagsk) View more	-	04 May 2025
P12-6.004 (AAN2025)	Not Applicable	B-Cell Malignant Neoplasm	49	Axicabtagene ciloleucel CART	vvxdadrbzf(dmqppusrvr) = qxuqpkquys tdfkxjelqo (hgivrhjlap ) View more	Positive	07 Apr 2025
NCT05108805 (Prospective Clinical Trial of Outpatient Administration of Axicabtagene Ciloleucel, CTgov)	Phase 4	Diffuse Large B-Cell Lymphoma	25	Telemedicine Visit+Axicabtagene Ciloleucel+Fludarabine+Cyclophosphamide	epvmvuvpkg = lwmwpnnyaz wzxjfxdpho (cyyxafarft, xxqvbvting - lweffiukbv) View more	-	27 Mar 2025
NCT04531046 (ALYCANTE, ASH2024)	Phase 2	Large B-cell lymphoma Second line	62	Axi-cel	shnmwtaand(knzgwknqpe) = exqsezyeym htrurggilb (twodrilvxy, -4.0 to 4.7) View more	Positive	09 Dec 2024
NCT04531046 (ALYCANTE, ASH2024)	Phase 2	Large B-cell lymphoma Second line	62	Placebo	zxbhvtxxvk(uiahbktjgz) = bcdbiluhqw zhfjakicnm (xmabztmfds, 17.9 - 29.6) View more	Positive	09 Dec 2024

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

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

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Axicabtagene Ciloleucel

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation