NCT07266337

CD19/BCMA CAR-T for SLE

Clinical Study on the Safety and Efficacy of CD19/BCMA CAR T-cell Therapy for Refractory Systemic Lupus Erythematosus

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Chengdu Ucello Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is to learn if CD19/BCMA CAR-T works to treat refractory SLE in adults. It will also learn about the safety and efficacy of the CD19/BCMA CAR-T cell product. The main questions it aims to answer are: 1. What CAR-T-related adverse events (AEs) occur within 3 months after the CAR-T cell infusion? 2. Which dose level is the optimal biological dose (OBD)? 3. What is the the changes of disease activity status, proportion of patients achieving DORIS remission, percentage of participants achieving maintenance of drug-free DORIS remission, proportion of patients achieving SRI-4 remission, percentage of participants achieving maintenance of LLDAS? Participants will: 1. Receive CD19/BCMA CAR-T cells infusion on Day 0. 2. Be hospitalized for at least 7 days post-infusion for close safety monitoring and remain within 2 hours of the treatment facility for at least 28 days. 3. Visit the clinic at Day 14, Day 28, month 3, month 6, month 9, month 12, month 18 and month 24 after CAR-T cells infusion.

Conditions

• SLE - Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	CD19/BCMA CAR T-cells	intravenous injection of CD19/BCMA CAR-T cells

Timeline

• Start date: 2025-12-10
• Primary completion: 2035-12-31
• Completion: 2037-12-31
• First posted: 2025-12-05
• Last updated: 2025-12-05

Locations

1 site across 1 country: China