Bioheng Therapeutics Wins Approval for CD7 UCAR-T Therapy in T-ALL/LBL

Bioheng Therapeutics has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application.

CTD402 is a universal CAR-T cell product targeting CD7. Developed from healthy donor cells, it is designed to avoid fratricide, graft-versus-host disease (GvHD), and host-versus-graft rejection (HvG), while improving anti-tumour activity.

The therapy is manufactured in a way that enables a single batch to treat multiple patients, supporting its potential as an off-the-shelf treatment option.

T-ALL and LBL are related blood cancers that develop from immature T-cell lymphoid cells. They are classified based on the extent of bone marrow involvement.

While standard treatments can achieve high complete remission (CR) rates, many patients eventually relapse. Relapsed or refractory (R/R) disease remains a significant challenge, with long-term survival rates of less than 20%.

The FDA’s clearance for CTD402 marks an important step towards addressing this urgent medical need.

The approval allows the company to proceed with clinical trials of CTD402, a CD7-targeted universal CAR-T (UCAR-T) cell therapy, for paediatric and adult patients with relapsed or refractory T-cell acute lymphoblastic leukaemia/lymphoma (R/R T-ALL/LBL).

The upcoming trial, a Phase Ib/II study, will follow a single-arm, open-label design with a simplified dose-finding approach.

This structure aims to optimise dosing and speed up clinical development in the United States.

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