CAR-T FDA Approvals, MOA, ROA, Clinical Trials, Emerging Drugs | DelveInsight

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

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Key Takeaways from the CAR-T Pipeline Report
• In January 2025:- Janssen Research & Development LLC;- The purpose of this study is to evaluate the overall minimal residual disease (MRD) negative rate of participants who receive JNJ-68284528.
• In January 2025:- Vor Biopharma:-This is a Phase 1/2, multicenter, open-label, first-in-human (FIH) study of donor-derived anti-CD33 Chimeric Antigen Receptor (CAR) T cell therapy (VCAR33) in patients with relapsed or refractory Acute Myeloid Leukemia (AML) after human leukocyte antigen (HLA)-matched allogeneic hematopoietic cell transplant (alloHCT).
• In January 2025:- AstraZeneca:- For Phase 2, it aims to evaluate the efficacy, to further characterize the safety of GC012F (AZD0120), pharmacodynamic effect, and immunogenicity, changes from baseline for subject-reported health-related quality of life, overall health status in subjects with relapsed/ refractory Multiple Myeloma.
• 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 Tâ„¢ known as a TurboCARâ„¢, 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.

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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

Discover the latest advancements in CAR-T treatment by visiting our website. Stay informed about how we're transforming the future of disease @ CAR-T Market Drivers and Barriers, and Future Perspectives- https://www.delveinsight.com/sample-request/car-t-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

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

For a detailed overview of our latest research findings and future plans, read the full details of CAR-T Pipeline on our website @ CAR-T Emerging Drugs and Companies- https://www.delveinsight.com/sample-request/car-t-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=ypr

Table of Content
1. Introduction
2. Executive Summary
3. CAR-T: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. CAR-T- DelveInsight's Analytical Perspective
7. Late Stage Products (Phase III)
8. Drug name: Company name
9. Drug profiles in the detailed report…..
10. Mid Stage Products (Phase II)
11. Descartes-08: Cartesian Therapeutics
12. Drug profiles in the detailed report…..
13. Early Stage Products (Phase I)
14. ATA3219: Atara Biotherapeutics
15. Drug profiles in the detailed report…..
16. Preclinical and Discovery Stage Products
17. Drug name: Company name
18. Drug profiles in the detailed report…..
19. Inactive Products
20. CAR-T Key Companies
21. CAR-T Key Products
22. CAR-T- Unmet Needs
23. CAR-T- Market Drivers and Barriers
24. CAR-T- Future Perspectives and Conclusion
25. CAR-T Analyst Views
26. CAR-T Key Companies
27. Appendix

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