Clinical Study of BCT301 Cell Injection Therapy for Refractory Autoimmune Diseases

This study primarily involves the use of BCT301, an anti-CD19 Chemically induced pluripotent stem cell (CiPSC)-derived CAR-iT cells, for the treatment of patients with refractory autoimmune diseases, aiming to evaluate its safety, tolerability, and dose-limiting toxicities(DLT), and to determine the recommended therapeutic dose for further investigation. Additionally, the study assesses the efficacy of BCT301 cell injection in refractory autoimmune diseases, as well as the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics in study participants.

NCT Number	NCT07301164
Lead Sponsor	Peking University Third Hospital
Conditions	System Lupus Erythematosus, Systemic Sclerosis (SSc), Inflammatory Myositis, Antiphospholipid Syndrome, ANCA Associated Vasculitis, Sjogren Syndrome
Enrollment	10 participants
Start Date	2025-12-11
Primary Completion	2027-12-31 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-12-24