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RECRUITING
NCT07523542
PHASE1/PHASE2

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

Sponsor: Beijing Biotech

View on ClinicalTrials.gov

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.

Official title: A Phase 1/2, Open-Label, Biomarker-Guided, Non-Randomized, Multicenter Study of Autologous CAR-T Cell Therapy Targeting CD19 or BCMA in Adults With Refractory Systemic Lupus Erythematosus With or Without Active Lupus Nephritis.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2026-03-02

Completion Date

2028-10-17

Last Updated

2026-04-13

Healthy Volunteers

No

Interventions

BIOLOGICAL

Autologous anti-CD19 CAR-T cells, intravenous single infusion at protocol-defined dose level (1 x 10^6 or 3 x 10^6 CAR-positive viable T cells/kg).

Autologous anti-CD19 CAR-T cells are patient-derived T lymphocytes that are genetically engineered to target CD19-expressing B cells. In clinical trials, a single intravenous infusion is administered at a protocol-defined dose (e.g., 1 × 10⁶ or 3 × 10⁶ CAR-positive viable T cells per kg) to evaluate safety, tolerability, and preliminary efficacy.

DRUG

Fludarabine

30 mg/m2/day IV on Days -5 to -3.

DRUG

Cyclophosphamide

300 mg/m2/day IV on Days -5 to -3.

Locations (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China