A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapsed / Refractory Systemic Lupus Erythematosus

NCT06920433 EARLY_PHASE1 RECRUITING

This is an open label, single-site, dose-escalation study in up to 18 participants with relapsed or refractory Systemic lupus erythematosus. This study aims to evaluate the safety and efficacy of the treatment with universal CD19/BCMA CAR T-cells.

Details

Lead sponsor	Zhejiang University
Phase	EARLY_PHASE1
Status	RECRUITING
Enrolment	18
Start date	2025-04-08
Completion	2027-11

Conditions

• Systemic Lupus Erythematosus

Interventions

• UCAR T-cell group

Primary outcomes

• The number and severity of dose-limiting toxicity (DLT) events — Within 28 Days After UCAR T-cell Infusion
  DLT will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, and the ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells.
• The total number, incidence, and severity of AEs — Up to 90 days After UCAR T-cell Infusion
• Clinical response — Up to 24 Months After UCAR T-cell Infusion
  SLE：SLE Response Index 4 (SRI-4) LN：Primary effcacy renal response（PERR）

Countries

China