CARsgen Announces Preliminary Clinical Data for Allogeneic BCMA CAR-T CT0596, Demonstrating Favorable Safety and Efficacy

Core Insights - CARsgen Therapeutics Holdings Limited announced preliminary clinical data for CT0596, an allogeneic BCMA-targeted CAR-T therapy, currently in exploratory clinical studies for relapsed/refractory multiple myeloma (R/R MM) and plasma cell leukemia (R/R PCL) [1][2] Group 1: Clinical Data and Efficacy - As of May 6, 2025, 8 patients with R/R MM were infused with CT0596 after lymphodepletion, showing favorable tolerability and encouraging efficacy signals across all predefined dose levels [2] - Among 5 patients who completed the first efficacy assessment at Week 4, 3 patients (60%) achieved stringent complete response/complete response (sCR/CR), and 4 patients (80%) achieved minimal residual disease (MRD)-negativity in the bone marrow [5] - Early efficacy data from 2 patients at Day 14 indicated reductions in measurable lesions by ≥92% and ≥65%, respectively [5] Group 2: Technology and Platform - CARsgen developed the THANK-u Plus™ platform to enhance CAR-T technology, demonstrating sustained expansion regardless of NKG2A expression levels on NK cells, with improved antitumor efficacy compared to the previous THANK-uCAR® [3] - The platform shows potential for developing diverse allogeneic CAR-T therapies, with CAR-T cells exhibiting robust antitumor activity in the presence of NK cells [3] Group 3: Company Overview - CARsgen is focused on innovative CAR T-cell therapies for unmet clinical needs, including hematologic malignancies, solid tumors, and autoimmune diseases [4] - The company has established end-to-end capabilities for CAR T-cell research and development, covering target discovery, preclinical research, clinical development, and commercial-scale production [4] - CARsgen aims to improve safety profiles, enhance efficacy in treating solid tumors, and reduce treatment costs, positioning itself as a global leader in biopharmaceuticals [4]