CARsgen Therapeutics (02171.HK) announced it will present clinical data on its allogeneic CAR-T cell candidate CT0596 at the 67th American Society of Hematology Annual Meeting, marking a significant milestone for the company's universal CAR-T therapy program targeting BCMA.
Novel Allogeneic CAR-T Platform Shows Promise
CT0596 represents a universal CAR-T cell therapy targeting BCMA, developed using CARsgen Therapeutics' proprietary THANK-u Plus platform. The therapy is currently being evaluated in investigator-initiated clinical trials for patients with relapsed/refractory multiple myeloma (R/R MM) or plasma cell leukemia (PCL).
According to the company, CT0596 has demonstrated preliminary favorable safety and encouraging efficacy signals in early clinical testing. Notably, CAR-T cell expansion was observed across all pre-set dose groups, indicating the therapy's potential for consistent therapeutic activity.
Expanding Therapeutic Applications
Beyond its current focus on relapsed/refractory multiple myeloma, CARsgen Therapeutics plans to explore CT0596's potential in treating other plasma cell malignancies. The company is also investigating the therapy's application in autoimmune diseases driven by autoreactive plasma cells, potentially expanding the treatment's utility beyond oncology.
Regulatory Timeline and Data Release
The company anticipates submitting an Investigational New Drug (IND) application for CT0596 in the second half of 2025. The abstract containing detailed clinical data and further information will be released after November 3, 2025, Eastern Time, coinciding with the ASH Annual Meeting presentation.
The presentation at ASH 2025 will provide the medical community with comprehensive insights into CT0596's clinical performance, safety profile, and efficacy data from the ongoing investigator-initiated trials.
