Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Inje
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA U CAR T cells in patients with autoimmune diseases. 60 patients are planned to be enrolled in the dose-escalation trial.
| Condition(s) | Autoimmune Diseases, Systemic Lupus Erythematosus, Systemic Sclerosis, Primary Sjögren Syndrome, Rheumatoid Arthritis, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis |
|---|---|
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Study type | Interventional |
| Summary | A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA U CAR T cells in patients with autoimmune diseases. 60 patients are planned to be enrolled in the dose-escalation trial. |
| Who can participate | Common inclusion criteria: 1. Age: ≥ 18 years old and ≤ 70 years old, male or female; 2. The functions of critical organs meet the following requirements: a )Neutrophil count ≥ 1 x 10\^9/L, Hemoglobin ≥60g/L; b) Liver function: ALT ≤ 3 x ULN,AST≤3 x ULN, TBIL≤1.5 x ULN; c) Coagulation function: International standardized ratio (INR) ≤1.5x ULN, prothrombin time (PT) ≤1.5 x ULN; d) Cardiac function: good hemodynamic stability, left ventricular ejection fraction (LVEF) ≥50%; 3. Female subjects of childbearing potential and male subjects whose partner is a female of childbearing potential are required to use medically approved contraception or abstain from sex for at least 6 months during and at least 6 months after the end of the study treatment period; female subjects of childbearing potenti |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | Changhai Hospital |
| Locations | Shanghai, China |
| Start date | 2026-02-20 |
| NCT ID | NCT07246096 |
| Official listing | https://clinicaltrials.gov/study/NCT07246096 |