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CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH
This is a single-center, open-label, non-randomized, single-arm clinical trial. Patients with refractory lupus neritis (SLE-LN), systemic sclerosis (SSc), and primary Sjogren syndrome combined with pulmonary artery hypertension (pSS-PAH) receive CD19-BCMA CAR T cell therapy. The primary objective is to prospectively assess the safety of CD19-BCMA CAR T cell therapy in patients with SLE-LN, SSc, and pSS-PAH. The primary endpoint is the type and incidence of dose-limiting toxicity (DLT) within 28 days after CD19-BCMA CAR T cell infusion.
Details
| Lead sponsor | Beijing GoBroad Hospital |
|---|---|
| Phase | PHASE1, PHASE2 |
| Status | RECRUITING |
| Enrolment | 45 |
| Start date | Fri Apr 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Fri Jul 31 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Refractory Lupus Nephritis
- Systemic Sclerosis
- Primary Sjogren's Syndrome Combined With Pulmonary Hypertension
Interventions
- CD19-BCMA CAR-T cells infusion
Countries
China