On February 9, 2025 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, reported that the first subject treated with an allogeneic BCMA CAR-T therapy developed on the THANK-u Plus platform, has achieved stringent complete response (sCR) and minimal residual disease (MRD) negativity at the Day-28 assessment (Press release, Carsgen Therapeutics, FEB 9, 2025, View Source [SID1234650118]).
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The patient, diagnosed with relapsed/refractory multiple myeloma, IgA-λ type (R-ISS Stage II), had previously undergone three lines of combination therapy along with autologous hematopoietic stem cell transplantation. After disease progression following the most recent treatment, the patient was enrolled in the clinical trial. Following infusion of CAR‑T cells at the lowest dose level according to the clinical protocol, the patient experienced Grade 1 cytokine release syndrome (CRS), which was effectively managed with antipyretics and tocilizumab, and the patient did not show immune effector cell-associated neurotoxicity syndrome (ICANS) or other CAR-T-related immune adverse events, demonstrating an overall favorable safety profile.
This CAR-T therapy is developed for the treatment of relapsed/refractory multiple myeloma (R/R MM) and relapsed/refractory plasma cell leukemia (R/R PCL). Additional data updates are anticipated in the second half of this year.
"Developed in-house, the THANK-u Plus platform is an innovative allogeneic CAR-T technology designed to overcome the accessibility challenges in CAR-T therapy. The expansion of CAR-T cells and the preliminary positive efficacy observed in the first subject further reinforce our confidence in the future of allogeneic CAR-T products development. We extend our sincere gratitude to the investigators for their invaluable collaboration and to the patients for participating in this trial—efforts that accelerate our mission to address unmet medical needs," said Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics.
About THANK-u Plus
CARsgen has developed the THANK-u Plus platform as an enhanced version of its proprietary THANK-uCAR allogeneic CAR-T technology to address the potential impact of NKG2A expression levels on therapeutic efficacy. THANK-u Plus demonstrates sustained expansion regardless of varying NKG2A expression levels on NK cells and exhibits significantly improved expansion compared to THANK-uCAR. Preclinical studies show that THANK-u Plus delivers superior antitumor efficacy in the presence of NK cells compared to THANK-uCAR. Allogeneic BCMA or dual-targeting CD19/CD20 CAR-T cells developed using this platform exhibit robust antitumor activity in the presence of NK cells, indicating that THANK-u Plus has broad potential for developing diverse allogeneic CAR-T therapies.