BOSTON, March 5, 2025 /PRNewswire/ -- Bioheng Therapeutics US LLC (“Bioheng”), a clinical-stage biotech company dedicated to developing innovative universal CAR-T cell therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for CTD402, a CD7-targeted universal CAR-T (UCAR-T) cell therapy, for the treatment of pediatric and adult patients with relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL). The study approved by the FDA is a single-arm, open-label Phase Ib/II trial with a simplified dose-finding design, designed to optimize dosing and accelerate clinical development.
“We are delighted that CTD402 has received IND clearance from the U.S. FDA for a Phase Ib/II trial with a simplified dose-finding design, accelerating our clinical development timeline in the United States,” stated Jiangtao Ren, Ph.D., President & Chief Scientific Officer (CSO) of Bioheng. “IIT study results showed an impressive ORR, alongside a favorable safety profile. These results validate our ANSWER® platform’s ability to deliver both rapid therapeutic impact and reduced patient risk, positioning CTD402 as a potential best-in-class therapy for T-cell malignancies.”
About CTD402
CTD402 is a universal CAR-T cell product targeting CD7 derived from healthy donors and intended for the treatment of T-ALL/LBL. It is genetically modified to avoid fratricide, graft-versus-host disease (GvHD), and host-versus-graft rejection (HvG) while enhancing anti-tumor activity. CTD402 can be prepared in a single batch for multiple people, achieving an “off-the-shelf” capability for patients in need of CAR-T cell therapy.
About T-ALL/LBL
T-ALL/LBL are distinct clinical presentations of the same malignancy, originating from immature T-cell lineage lymphoid cells and classified based on the degree of bone marrow involvement. [1] While frontline therapy achieves high complete remission (CR) rates, the majority of patients ultimately experience relapse. Relapsed or refractory (R/R) disease is associated with poor outcomes, with a 5-year overall survival (OS) rate of less than 20%.[2]
About Bioheng
Bioheng Therapeutics is a clinical-stage company focused on allogeneic “off-the-shelf " universal CAR-T therapies. Founded in 2017, we aim to develop the world’s leading allogeneic cell therapy platforms and products to address some of the most challenging unmet needs.
References:
[1] Swerdlow S H, Campo E, Pileri S A, et al. The 2016 revision of the World Health Organization classification of lymphoid neoplasms[J]. Blood, The Journal of the American Society of Hematology, 2016, 127(20): 2375-2390.
[2] Marks D I, Rowntree C. Management of adults with T-cell lymphoblastic leukemia[J]. Blood, The Journal of the American Society of Hematology, 2017, 129(9): 1134-1142.
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SOURCE Bioheng Therapeutics US LLC
