Phase IIIa Study of Universal Allogeneic CAR-T Cells Targeting CD19 and BCMA for Treating Adults with Refractory Systemic Lupus Erythematosus

What this Trial Is About

Researchers are evaluating the safety and tolerability of QT-019B, a dual-target, universal CAR-T cell therapy for adults with refractory systemic lupus erythematosus SLE. This phase IIIa clinical study aims to determine the recommended dose RD and understand how the treatment affects disease activity in patients who have not responded to standard therapies. The study is sponsored by Hangzhou Qihan Biotech Co., Ltd. and plans to enroll between 18 and 24 participants. The study consists of two main phases dose escalation and dose expansion. Initially, participants receive a QT-019B cell injection at Dose A 1106kg, with a 14-day interval between enrollments. If no dose-limiting toxicities DLTs are observed during the observation period, the study may proceed to Dose B 3106kg. If DLTs occur, additional participants may be enrolled at Dose A, or the study dose may be reduced or the study terminated depending on the number of DLTs observed. Participants will be closely monitored through safety assessments including tracking adverse events within 28 days of treatment. Researchers will also evaluate changes in disease activity scores such as the SLEDAI-2000, Physicians Global Assessment, and BILAG-2004 Index over up to two years. Blood samples will be collected to measure the concentration and behavior of QT-019B cells. The overall study involves regular visits, assessments, and follow-up to comprehensively evaluate safety and treatment impact over time.

A Clinical Study of Dual-Target, Universal CAR-T Cell Therapy for Refractory Systemic Lupus Erythematosus