drugset / Trial / NCT07523542
SELECT-SLE: Biomarker-Guided CAR-T Target Selection for Refractory Lupus
Non-randomizedParallel-groupOpen-labelTreatment
Summary
study evaluates a biomarker-guided strategy to assign adults with refractory SLE to autologous CAR-T therapy targeting either CD19 or BCMA. Participants undergo centralized screening immunophenotyping to determine whether their disease appears B-cell-dominant (CD19-preferred) or plasma-cell-dominant (BCMA-preferred), followed by leukapheresis, lymphodepletion, and a single CAR-T infusion. The main goals are to assess safety, determine a recommended Phase 2 dose within each arm, and estimate remission rates by Week 24.
Timeline
- Start
- 2026-03-02
- Primary completion
- 2027-03-14
- Completion
- 2028-10-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Autologous anti-CD19 CAR-T cells | Cell therapy | 1e+06 cells/kg | Intravenous |
| Subject | Autologous anti-CD19 CAR-T cells | Cell therapy | 3e+06 cells/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 300 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |