CD19 CAR T-Cell Therapy for Refractory Systemic Lupus Erythematosus

The goal of this Phase I clinical trial is to evaluate the safety and tolerability of autologous CD19-targeted chimeric antigen receptor T-cell (CAR-T) therapy in adults with refractory systemic lupus erythematosus who have demonstrated inadequate response to standard-of-care immunosuppressive treatments. The primary questions this study aims to address are: What is the incidence, nature, and severity of treatment-emergent adverse events following CD19 CAR-T cell infusion? Is administration of CD19 CAR-T cell therapy feasible and tolerable in patients with refractory systemic lupus erythematosus? This study is conducted as a single-arm trial without a comparison group. Participants will: Undergo leukapheresis for collection of autologous peripheral blood mononuclear cells Receive a protocol-defined lymphodepleting chemotherapy regimen prior to CAR-T cell infusion Receive a single intravenous infusion of approximately 1.0 × 10⁶ CD19 CAR-T cells per kilogram of body weight Undergo scheduled clinical evaluations, laboratory testing, and longitudinal follow-up to assess safety, tolerability, and clinical parameters

NCT Number	NCT07432334
Lead Sponsor	Vinmec Research Institute of Stem Cell and Gene Technology
Conditions	Refractory Systemic Lupus Erythematosus
Enrollment	8 participants
Start Date	2026-03-01
Primary Completion	2027-09 (estimated)
Study Completion	2027-11 (estimated)
Updated on ClinicalTrials.gov	2026-07-09