Sequential CAR-T Cells Targeting BCMA/CD19 in Patients With Relapsed/ Refractory Autoimmune Diseases

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

May 29, 2024

Primary Completion Date

December 10, 2025

Study Completion Date

December 28, 2026

Conditions
Autoimmune DiseasesSystemic Lupus ErythematosusSystemic Lupus Erythematosus AcuteSjogren's Syndrome
Interventions
BIOLOGICAL

BCMA/CD19 CAR-T cells

"The intervention in this clinical trial involves a novel approach using BCMA/CD19 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.~BCMA/CD19 Chimeric Antigen Receptor T Cells (Day 0): IV administration of investigational therapy, BCMA/CD19 CAR T cells, over 10-20 minutes on day 0.~Additional Doses: Eligible patients responding well to the initial BCMA/CD19 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