Pharma Focus Asia

FDA Approves IND for Carsgen's CT071 in the Treatment of Relapsed/refractory Multiple Myeloma and Relapsed/refractory Primary Plasma Cell Leukemia

Tuesday, December 05, 2023

CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK) has obtained Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for CT071, an autologous CAR T-cell therapy designed to target G protein-coupled receptor class C group 5 member D (GPRC5D). This therapy is intended for treating patients with relapsed/refractory multiple myeloma (MM) or relapsed/refractory primary plasma cell leukemia (PCL).

GPRC5D has emerged as a crucial target in the context of MM, a prevalent yet incurable hematologic malignancy characterized by the uncontrolled proliferation of plasma cells. The significant overexpression of GPRC5D on malignant plasma cells, coupled with its limited presence on normal tissues, positions GPRC5D as an ideal candidate for MM and PCL treatment. CT071 utilizes a fully-human single-chain variable fragment (scFV) developed by CARsgen, specifically designed to target GPRC5D.

The manufacturing of CT071 is facilitated by CARsgen's proprietary CARcelerateTM platform, streamlining the process to less than 2 days, resulting in younger, healthier, and potentially more potent CAR T cells compared to traditional manufacturing methods. This increased manufacturing efficiency not only enhances supply capacity but also reduces costs, expediting product availability to patients.

In China, an investigator-initiated trial (IIT) is currently underway (NCT05838131) to assess CT071's safety and efficacy in treating relapsed/refractory MM or PCL. Preliminary clinical data from this trial demonstrates an acceptable safety profile with promising efficacy.

CT071 is a CAR T-cell therapy candidate developed by CARsgen using the proprietary CARcelerateTM platform, targeting GPRC5D for treating relapsed/refractory MM or relapsed/refractory PCL. An ongoing investigator-initiated trial (NCT05838131) in China aims to evaluate its safety and efficacy for treating relapsed/refractory multiple myeloma or plasma cell leukemia.

CARcelerateTM is a proprietary platform developed by CARsgen, designed to shorten the manufacturing time for CAR T cells to less than 2 days, compared to conventional CAR T manufacturing processes. The CARcelerateTM platform produces CAR T cells that are younger, healthier, more likely to remain in a 'naïve' state, and less likely to be exhausted, potentially exhibiting more potent tumor-killing activity.



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