Bioheng Therapeutics Receives FDA IND Approval for Allogeneic CD19/BCMA CAR-T Therapy CTA313 in B-Cell-Mediated Autoimmune Diseases

On June 9, 2026, Nanjing Bioheng Biotech Co., Ltd. issued an announcement stating that its dual-target CD19/BCMA allogeneic CAR-T cell therapyCTA313'sInvestigational New Drug Application (IND)IND Approved by the U.S. FDA for the Treatment ofB cell-mediated autoimmune diseases.

CTA313 is a clinical-stageAllogeneic CD19/BCMA CAR-T Cell Therapy, Derived from Healthy Donor PBMCs, for the Treatment of B Cell-Mediated Autoimmune DiseasesThis product utilizes Bioheng Biotech’s proprietary ANSWER™ inhibitory ligand and gene-editing technologies to enhance its resistance to host immune rejection, thereby improving therapeutic durability.

As an allogeneic CAR-T therapy,CTA313It can be manufactured and stored in advance, with a single production batch suitable for treating multiple patients, providing an "off-the-shelf" therapeutic solution for patients requiring CAR-T cell therapy.

Currently,CTA313 has been evaluated in investigator-initiated trials (IITs) conducted in China, covering multiple autoimmune-related indications across disease areas including nephrology, rheumatology, endocrinology, gastroenterology, and hematology.

Following FDA IND approval, Nanjing Bioheng Biotech Co., Ltd. is poised to commence operations in the United StatesPhase I Clinical Trial of CTA313.

According to the disclosure, thisFDA-Approved Phase 1b Basket Study Design to Evaluate the Safety, Efficacy, and Cellular Pharmacokinetic Profile of CTA313 in Multiple B Cell-Mediated Autoimmune Diseases, Including Systemic Lupus Erythematosus (SLE), Progressive Multiple Sclerosis (pMS), and Autoimmune Encephalitis (AE)

This basket study design facilitates the efficient exploration of the feasibility of CTA313 across multiple indications, while maintaining the flexibility to advance indications with positive signals into Phase II clinical development.