RecruitingPhase 1Phase 2NCT07523542

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

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.

Sponsor

Beijing Biotech

Enrollment

24 participants

Start Date

Mar 2, 2026

Study Type

INTERVENTIONAL

Conditions

Lupus Nephritis Refractory Systemic Lupus Erythematosus

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Autologous anti-CD19 CAR-T cells, intravenous single infusion at protocol-defined dose level (1 x 10, a drug called Cyclophosphamide, and others for people with lupus nephritis and refractory systemic lupus erythematosus. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALAutologous 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.

DRUGFludarabine

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

DRUGCyclophosphamide

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