NCT06775912 Clinical Study on Targeted CD19/BCMA CAR-T Therapy for Autoimmune Diseases
| NCT ID | NCT06775912 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Nanjing Bioheng Biotech Co., Ltd. |
| Condition | SLE |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2025-01-03 |
| Primary Completion | 2027-01-01 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with active SLE, SSc, AAV, IIM, NMOSD, MS, MG
Eligibility Criteria
Inclusion Criteria: 1. The subjects voluntarily participated in the study and signed the informed consent form. 2. Age ≥18 years old and ≤70 years old, both sexes. 3. Organ function and laboratory tests: 1. Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3× upper limit of normal (ULN), total bilirubin (TBIL) ≤2×ULN (except Gilbert's syndrome). 2. Renal function: creatinine ≤1.5×ULN or creatinine clearance ≥40 ml/min. 3. Blood routine: neutrophil count ≥1×109/L, hemoglobin ≥60g/L, platelet count ≥20×109/L, lymphocyte count \>0.3×109/L. 4. Coagulation: international normalized ratio (INR) ≤ 1.5×ULN, or prothrombin time (PT) ≤ 1.5×ULN. 5. Oxygen saturation (SpO2) ≥92% at rest in room air. 6. Left ventricular ejection fraction (LVEF) ≥50% on echocardiography. 4. Negative serum or urine pregnancy test results in female subjects of childbearing potential at screening. 5. Women of childbearing potential must agree to use a highly effective method of contra