US EditionCARsgen Submits Dual IND Applications for Allogeneic BCMA CAR-T Product CT0596
CARsgen seeks regulatory approval to start two Phase Ib/a trials for CT0596, showing favorable safety and efficacy in early studies for relapsed/refractory multiple myeloma and plasma cell leukemia.
- On Dec. 28, 2025, CARsgen Therapeutics Holdings Limited submitted two IND applications to the National Medical Products Administration for CT0596 to start Phase Ib/a trials for multiple myeloma and plasma cell leukemia.
- Engineered to reduce immune complications, CT0596 uses CARsgen's THANK‑u Plus platform with knockouts of NKG2A, TRAC and B2M to limit graft‑versus‑host disease and natural killer cell rejection.
- Data from the 2025 ASH Annual Meeting showed Six patients achieved PR or better, including two pPCL patients with sCR, with no ICANS, GvHD, DLTs or deaths and Four with Grade 1 CRS.
- The IND filings begin the registration clinical development phase, building on investigator‑initiated trials in China to inform planned Phase Ib/a clinical trials for patients with R/R MM and pPCL.
- With end‑to‑end R&D capabilities, CARsgen Therapeutics Holdings Limited is positioned to leverage in‑house technologies and product pipeline with global rights for broader development of CT0596, planning further investigation in plasma cell malignancies and autoimmune diseases mediated by plasma cells.
38 Articles
38 Articles
The Berkshire Eagle
CARsgen Submits Dual IND Applications for Allogeneic BCMA CAR-T Product CT0596
SHANGHAI, Dec. 28, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announced that it has submitted two separate Investigational New Drug (IND) applications to the National Medical Products Administration…
CARsgen submits dual IND for allogeneic BCMA CAR T product
SHANGHAI, Dec. 29, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announced that it has submitted two separate Investigational New Drug (IND) applications to the National Medical Products Administration (NMPA) for its allogeneic BCMA-targeted CAR-T cell therapy product, CT0596. The applications seek to initiate two corresponding Phase Ib/Ⅱ clinica…
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