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CARsgen Submits Dual IND Applications for Allogeneic BCMA CAR-T Product CT0596
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 clinical trials for the treatment of relapsed/refractory multiple myeloma (R/R MM) and primary pla
About this update from Carsgen Therapeutics Holdings Ltd.
[{"type":"text","content":"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 (NMPA) for its allogeneic BCMA-targeted CAR-T cell therapy product, CT0596. The applications seek to initiate two corresponding Phase Ib/Ⅱ clinical trials for the treatment of relapsed/refractory multiple myeloma (R/R MM) and primary plasma cell leukemia (pPCL), respectively.","length":584,"tagName":"p"},{"type":"image","alt":"(PRNewsfoto/科济药业)","displaySize":"","headline":null,"caption":"(PRNewsfoto/科济药业)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":400,"url":"https://media.zenfs.com/en/prnewswire.com/5526ae7fcec6d3697a745ab2d0333d4b"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/pxBnvmJ9CDgFxmtruRHsdQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTcwNTtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/5526ae7fcec6d3697a745ab2d0333d4b","width":400,"height":400}},"href":"https://mma.prnewswire.com/media/1722549/Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"CT0596 is an allogeneic CAR T-cell therapy targeting BCMA, developed based on CARsgen's proprietary THANK-u Plus™ platform. Through the knockout of genes such as NKG2A, TRAC, and B2M, CT0596 is designed to reduce the risk of graft-versus-host disease (GvHD) and host immune rejection. Additional gene editing further blocks host natural killer (NK) cell-mediated rejection, thereby aiming to enhance the product's efficacy and safety profile.","length":450,"tagName":"p"},{"type":"text","content":"Investigator-initiated trials (IIT) for CT0596 have already been conducted in China to explore its clinical potential in treating R/R MM and pPCL. Data from the first-in-human study, presented at the 2025 American Society of Hematology (ASH) Annual Meeting, demonstrated a favorable safety profile and encouraging efficacy signals for CT0596. As of August 31, 2025, all 8 patients with R/R MM who received CT0596 infusion were evaluable for efficacy, with a median follow-up of 4.14 months. Six patients achieved a partial response (PR) or better: 3 achieved complete response/stringe...