A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse/Refractory Autoimmune Diseases

NCT06978738 Phase 1 NOT_YET_RECRUITING

This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells in With Relapse/Refractory Autoimmune Diseases.

Details

Lead sponsor	Changzhou No.2 People's Hospital
Phase	Phase 1
Status	NOT_YET_RECRUITING
Enrolment	18
Start date	2025-05
Completion	2028-11

Conditions

• Systemic Lupus Erythematosus
• Autoimmune Hemolytic Anemia
• Myasthenia Gravis
• Systemic Sclerosis
• ANCA-Associated Vasculitis
• Inflammatory Myopathy
• IgG4-RD

Interventions

• universal allogeneic anti-CD19/BCMA CAR T-cells

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

Countries

China