FDA Approves Investigational New Drug Application for CTD402 in T-ALL/LBL

Bioheng Therapeutics announced that the FDA has approved its Investigational New Drug (IND) application  for CTD402, a CD7-targeted universal chimeric antigen receptor T-cell  (UCAR-T) therapy, for the treatment of pediatric and adult patients with relapsed or refractory T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LBL).¹

After the IND approval, CTD402 will be studied in a single-arm, open-label, phase 1b/2 trial aimed at optimizing dosing with a simplified dose-finding design and accelerating clinical development of CTD402.¹

The off-the-shelf UCART therapy is genetically modified to prevent graft-vs-host-disease and host-versus-graft rejection while improving antitumor activity, according to the company.¹

“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,” said Jiangtao Ren, PhD, president & chief scientific officer of Bioheng, in the press release.¹ “IIT [investigator-initiated trial] study results showed an impressive ORR [overall response rate], 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.”

Since 2020, the company has treated about 100 patients with CD7 UCAR-T therapy through their ANSWER platform, a novel and proprietary UCAR-T therapy technology platform.²

Reference

1. Bioheng Therapeutics announces FDA clearance of IND application for CD7 UCAR T cell therapy in T-ALL/LBL. PR Newswire. March 5, 2025. Accessed March 10, 2025. https://www.prnewswire.com/news-releases/bioheng-therapeutics-announces-fda-clearance-of-ind-application-for-cd7-ucar-t-cell-therapy-in-t-alllbl-302392846.html
2. About Bioheng Therapeutics. Bioheng Therapeutics. Accessed March 10, 2025. https://www.bioheng.com/