Trials / Not Yet Recruiting
Not Yet RecruitingNCT07490275
Allogeneic CD19/BCMA-Targeted CAR-γδT Cell Therapy: Safety and Preliminary Pharmacodynamics in Relapsed/Refractory Autoimmune Diseases
Safety and Preliminary Pharmacodynamics of Allogeneic CD19/BCMA-Targeted CAR-γδT Cell Therapy in Patients With Relapsed/Refractory Autoimmune Diseases
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (estimated)
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is a single-arm, intervention, dose-escalation clinical trial to evaluate the safety of allogeneic CD19/BCMA-targeted CAR-γδT cell in the treatment of relapsed/refractory autoimmune diseases
Conditions
- Refractory/Relapsed Systemic Lupus Erythematosus
- Refractory / Relapsed / Progressive Systemic Sclerosis
- Refractory / Relapsing / Progressive Inflammatory Myopathy
- Refractory / Relapsed Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis
- Refractory / Relapsed Connective Tissue Disease-Associated Thrombocytopenia
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Allogeneic CD19/BCMA-targeted CAR-γδT cell injection | Biological: Allogeneic CD19/BCMA-targeted CAR-γδT cell. Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine), patients will be treated with dose-escalation phase (3+3 design): Dose A (5 × 10\^6 CAR+cells) ,Dose B(1 × 10\^7 CAR+cells), Dose C (1.5 × 10\^7 CAR+cells). |
| DRUG | Cyclophosphamide | Eligible subjects will undergo lymphodepletion chemotherapy 5 to 3 days prior to cell infusion. The recommended lymphodepletion regimen comprises cyclophosphamide (300 mg/m² administered 3 days). |
| DRUG | Fludarabine | Eligible subjects will undergo lymphodepletion chemotherapy 5 to 3 days prior to cell infusion. The recommended lymphodepletion regimen comprises fludarabine (30 mg/m² administered 3 days). |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2028-12-31
- Completion
- 2028-12-31
- First posted
- 2026-03-24
- Last updated
- 2026-03-24
Source: ClinicalTrials.gov record NCT07490275. Inclusion in this directory is not an endorsement.