CAR-T Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight's, "CAR-T Pipeline Insight 2025" report provides comprehensive insights about 180+ companies and 200+ pipeline drugs in CAR-T pipeline landscape. It covers the CAR-T pipeline drug profiles, including clinical and nonclinical stage products. It also covers the CAR-T pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive CAR-T pipeline products in this space.

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Key Takeaways from the CAR-T Pipeline Report

* In March 2025, BeiGene announced a study is to compare how well sonrotoclax plus zanubrutinib works versus zanubrutinib plus placebo in treating adults with relapsed/refractory (R/R) mantle cell lymphoma (MCL). This study will also look at the safety of sonrotoclax plus zanubrutinib versus zanubrutinib plus placebo.
* In March 2025, Celgene announced a study is to compare the effectiveness and safety of golcadomide in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy vs placebo in combination with R-CHOP chemotherapy in participants with previously untreated high-risk large B-cell lymphoma (LBCL).
* In March 2025, Hoffmann-La Roche announced a study is to compare the efficacy and safety of glofitamab in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) vs Pola-R-CHP in participants with previously untreated CD20-positive large B-cell lymphoma (LBCL).
* In March 2025, Allogene Therapeutics announced a study in adult patients who have completed standard first line of therapy for large B-cell lymphoma (LBCL) and achieved a complete response or partial response suitable for observation, but who have minimal residual disease (MRD) as detected by the Foresight CLARITY Trademark Investigational Use Only (IUO) MRD test, powered by PhasED-Seq Trademark . The purpose of the trial is to assess the efficacy and safety of consolidation with cemacabtagene ansegedleucel (cema-cel), an allogeneic CD19 CAR T product, as compared to standard of care observation.
* In March 2025, Regeneron Pharmaceuticals announced a study study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on patients with previously treated aggressive B-cell non-Hodgkin lymphoma whose cancer has stopped responding to treatment (also known as 'refractory') or has returned (also known as 'relapsed'). The aim of the study is to see how safe, tolerable and effective the study drug is when given alone.
* In March 2025, Genmab announced a phase 3, Multicenter, Randomized, Open-Label Study of Epcoritamab Plus Lenalidomide Compared to Rituximab Plus Gemcitabine and Oxaliplatin in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
* DelveInsight's CAR-T pipeline report depicts a robust space with 180+ active players working to develop 200+ pipeline therapies for CAR-T treatment.
* The leading CAR-T Companies such as Caribou Biosciences, Allogene Therapeutics, Synthekine, Shanghai Simnova Biotechnology, Sana Biotechnology, Zhejiang University, Janssen Research & Development, Beijing Immunochina Medical Science & Technology, M.D. Anderson Cancer Center, SecuraBio, CARsgen Therapeutics, Atara Biotherapeutics, Wugen, Vor Biopharma, Juventas Cell Therapy, Hebei Senlang Biotechnology, Cellular Biomedicine Group, Oncternal Therapeutics, Autolus Limited, Lyell Immunopharma, Gracell Biopharmaceuticals , and others.
* Promising CAR-T Therapies such as IM23, C-CAR066, AJMUC1- PD-1 gene knockout anti-MUC1 CAR-T cells, Fludarabine, Cyclophosphamide, and others.

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CAR-T Emerging Drugs Profile

* Descartes-08: Cartesian Therapeutics

Descartes-08 is an autologous anti-B cell maturation antigen (BCMA) mRNA CAR-T. Compared to conventional DNA-based CAR T-cell therapies, mRNA CAR-T is designed not to require preconditioning chemotherapy, has been observed to have predictable and controllable pharmacokinetics, and is designed to avoid the risk of genomic integration. Descartes-08 has been granted Orphan Drug Designation by the US FDA for the treatment of MG, a chronic autoimmune disorder that causes disabling muscle weakness and fatigue. Currently, the drug is in Phase II stage of clinical trial for the treatment of autoimmune disorders.

* KYV-101: Kyverna Therapeutics

KYV-101 is an autologous, fully human CD19 CAR T-cell product candidate for use in B cell-driven autoimmune diseases. The CAR in KYV-101 was designed by the National Institutes of Health (NIH) to improve tolerability and tested in a 20-patient Phase 1 trial in oncology. Results were published by the NIH in Nature Medicine3. KYV-101 is currently being evaluated in sponsored, open-label, Phase 1/2 trials of KYV-101 in patients with lupus nephritis, an autoimmune disease in which more than half of patients do not achieve a complete response to current therapies and are at risk of developing kidney failure. Additionally, FDA's IND clearance has been obtained for Phase 2 trials of KYV-101 for multiple sclerosis and myasthenia gravis, and a Phase I/II trial for systemic sclerosis.

* TX200: Sangamo Therapeutics

TX200 is composed of the patient's own (autologous) regulatory T cells (Tregs) engineered to express a chimeric antigen receptor (CAR) designed to recognize the HLA-A2 protein present on a transplanted kidney and bind to it. TX200 is in development for the prevention of immune-mediated rejection in HLA-A2 mismatched kidney transplantation from a living donor. It is in Phase I/II stage of its clinical trial.

* ALLO-605: Allogene Therapeutics

ALLO-605, a next-generation AlloCAR T Trademark known as a TurboCAR Trademark , is an investigational product that targets the B-cell maturation antigen (BCMA) for the treatment of patients with relapsed/refractory multiple myeloma and other BCMA-positive malignancies. This study uses ALLO-647, Allogene's proprietary monoclonal antibody (mAb), as a part of its differentiated lymphodepletion regimen. ALLO-605 incorporates Allogene's proprietary TurboCAR technology, which allows for cytokine activation signaling to be engineered selectively into CAR T cells. In June 2021, ALLO-605 was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of relapsed/refractory multiple myeloma. The Phase 1 study evaluating ALLO-605 is underway. Currently, the drug is in Phase I/II stage of its clinical trial for the treatment of Multiple Myeloma.

* ATA3219: Atara Biotherapeutics

ATA3219 combines the natural biology of unedited T cells with the benefits of an allogeneic therapy. It consists of allogeneic Epstein-Barr virus (EBV)-sensitized T cells that express a CD19 CAR construct for the treatment of CD19+ relapsed or refractory B-cell malignancies, including B-cell non-Hodgkin's lymphoma and B-cell mediated autoimmune diseases including systemic lupus erythematosus (SLE) with kidney involvement (lupus nephritis [LN]). ATA3219 has been optimized to offer a potential best-in-class profile, featuring off-the-shelf availability. Currently, the drug is in Phase I stage of its clinical trial.

* CB-010 : Caribou Biosciences

CB-010 is an allogeneic anti-CD19 CAR-T cell therapy for the treatment of patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). CB-010 is the first allogeneic CAR-T cell therapy, to our knowledge, in a clinical trial with a PD-1 knockout, a genome-editing strategy designed to improve antitumor activity by limiting premature CAR-T cell exhaustion. CB-010 is being evaluated in the ongoing, open-label, multicenter ANTLER Phase I clinical trial in adults with r/r B-NHL.

The CAR-T Pipeline Report Provides Insights into

* The report provides detailed insights about companies that are developing therapies for the treatment of CAR-T with aggregate therapies developed by each company for the same.
* It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for CAR-T Treatment.
* CAR-T Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
* CAR-T Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
* Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the CAR-T market

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CAR-T Companies

Caribou Biosciences, Allogene Therapeutics, Synthekine, Shanghai Simnova Biotechnology, Sana Biotechnology, Zhejiang University, Janssen Research & Development, Beijing Immunochina Medical Science & Technology, M.D. Anderson Cancer Center, SecuraBio, CARsgen Therapeutics, Atara Biotherapeutics, Wugen, Vor Biopharma, Juventas Cell Therapy, Hebei Senlang Biotechnology, Cellular Biomedicine Group, Oncternal Therapeutics, Autolus Limited, Lyell Immunopharma, Gracell Biopharmaceuticals, and others.

CAR-T pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

* Oral
* Intravenous
* Subcutaneous
* Parenteral
* Topical

CAR-T Products have been categorized under various Molecule types such as

* Recombinant fusion proteins
* Small molecule
* Monoclonal antibody
* Peptide
* Polymer
* Gene therapy

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Scope of the CAR-T Pipeline Report

* Coverage- Global
* CAR-T Companies- Caribou Biosciences, Allogene Therapeutics, Synthekine, Shanghai Simnova Biotechnology, Sana Biotechnology, Zhejiang University, Janssen Research & Development, Beijing Immunochina Medical Science & Technology, M.D. Anderson Cancer Center, SecuraBio, CARsgen Therapeutics, Atara Biotherapeutics, Wugen, Vor Biopharma, Juventas Cell Therapy, Hebei Senlang Biotechnology, Cellular Biomedicine Group, Oncternal Therapeutics, Autolus Limited, Lyell Immunopharma, Gracell Biopharmaceuticals , and others.
* CAR-T Therapies- IM23, C-CAR066, AJMUC1- PD-1 gene knockout anti-MUC1 CAR-T cells, Fludarabine, Cyclophosphamide , and others.
* CAR-T Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* CAR-T Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

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Table of Content

* Introduction
* Executive Summary
* CAR-T: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* CAR-T- DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* Drug name: Company name
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* Descartes-08: Cartesian Therapeutics
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I)
* ATA3219: Atara Biotherapeutics
* Drug profiles in the detailed report.....
* Preclinical and Discovery Stage Products
* Drug name: Company name
* Drug profiles in the detailed report.....
* Inactive Products
* CAR-T Key Companies
* CAR-T Key Products
* CAR-T- Unmet Needs
* CAR-T- Market Drivers and Barriers
* CAR-T- Future Perspectives and Conclusion
* CAR-T Analyst Views
* CAR-T Key Companies
* Appendix

About Us

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