#United States #Boston #CAR-T therapy #Bioheng Therapeutics #T-ALL

Bioheng Therapeutics Gains FDA Clearance for CD7 CAR-T Cell Therapy

On March 5, 2025, Bioheng Therapeutics US LLC, a pioneering clinical-stage biotechnology firm, announced a significant milestone in its mission to revolutionize cancer treatment. The U.S. Food and Drug Administration (FDA) has granted approval for their Investigational New Drug (IND) application concerning CTD402, a groundbreaking universal CAR-T cell therapy specifically targeting CD7. This innovation is geared towards treating both pediatric and adult patients suffering from relapsed or refractory T-cell acute lymphoblastic leukemia and lymphoma (R/R T-ALL/LBL).

Accelerating Clinical Development

Jiangtao Ren, Ph.D., who serves as the President and Chief Scientific Officer of Bioheng, expressed enthusiasm regarding the FDA's endorsement. He highlighted that the clearance not only validates their efforts but also accelerates the clinical development timeline for CTD402 within the United States. The approved study is designed as a single-arm, open-label Phase Ib/II trial. This streamlined approach is geared towards optimizing dosages and hastening the introduction of this therapy into clinical practice.

Ren mentioned, "Clinical trials conducted previously have shown a remarkable overall response rate (ORR) paired with a commendable safety profile. This data showcases the potential of our ANSWER® platform in delivering rapid therapeutic impacts whilst aiming to minimize risks for patients, establishing CTD402 as a leading candidate in the treatment of T-cell malignancies."

Understanding CTD402

CTD402 is characterized as a universal CAR-T cell product, deriving its components from healthy donors. Its design aims to mitigate the risks of fratricide, graft-versus-host disease (GvHD), and host-versus-graft rejection (HvG), all while amplifying its anti-tumor effectiveness. Notably, CTD402's