Fourth-gen CAR T Cells Targeting BCMA/CD19 for Refractory Systemic Lupus Erythematosus (SLE)

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

July 10, 2024

Primary Completion Date

December 10, 2025

Study Completion Date

December 28, 2025

Conditions
Systemic Lupus ErythematosusLupus NephritisAutoimmune DiseasesAnti-Neutrophil Cytoplasmic Antibody-Associated VasculitisGranulomatous PolyangiitisMicroscopic PolyangiitisSystemic SclerosisIdiopathic Inflammatory MyopathiesSjogren's Syndrome
Interventions
BIOLOGICAL

CD19- BCMA CAR-T cells

"The intervention in this clinical trial involves a novel approach using CD19/BCMA-Chimeric Antigen Receptor T (CAR T) cells combined with chemotherapy. The goal is to assess safety and efficacy in patients with specific hematologic malignancies.~Treatment Regimen:~Patients in the trial will undergo the following regimen:~Fludarabine Phosphate (Days -4 to -2): IV administration of fludarabine phosphate over 30 minutes on days -4 to -2. It's part of the preparatory regimen to enhance the body's response to CAR T-cell therapy.~Cyclophosphamide (Day -2): IV cyclophosphamide over 60 minutes on day -2.~CD19/BCMA-Chimeric Antigen Receptor T Cells (Day 0): IV administration of investigational therapy, CD19/BCMA-CAR T cells, over 10-20 minutes on day 0.~Additional Doses: Eligible patients responding well to the initial CD19/BCMA-CAR T cell infusion without unacceptable side effects and sufficient CAR T cell availability may receive 2 or 3 additional doses."

Trial Locations (1)

086-373

RECRUITING

District One Hospital, Beijing

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Essen Biotech

OTHER