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SELECT-SLE: Biomarker-Guided CAR-T Target Selection for Refractory Lupus

Study acronym: SELECT-SLE
StatusRecruiting
PhasePhase 1/2
Started2026-03-02
View on ClinicalTrials.gov ↗
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.
Trial Details
NCT Number NCT07523542
Lead Sponsor Beijing Biotech
Conditions REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS, Lupus Nephritis
Enrollment 24 participants
Start Date 2026-03-02
Primary Completion 2027-03-14 (estimated)
Study Completion 2028-10-17 (estimated)
Updated on ClinicalTrials.gov 2026-04-13