RecruitingPhase 1Phase 2NCT06350110

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

T-cell Infusion Targeting BCMA and CD19 for Refractory/Relapsed Systemic Lupus Erythematosus (SLE) Patients With or Without Organs Involvement

Sponsor

Essen Biotech

Enrollment

75 participants

Start Date

Jul 10, 2024

Study Type

INTERVENTIONAL

Conditions

Systemic Lupus Erythematosus Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Sjogren's Syndrome Autoimmune Diseases Idiopathic Inflammatory Myopathies Systemic Sclerosis Lupus Nephritis Granulomatous Polyangiitis Microscopic Polyangiitis

Summary

This study is a preliminary investigation, with a single-group design, not randomized and transparent, focusing on treatment. Its purpose is to identify the highest dose of BH002 injection (CD19-BCMA CAR-T cells) that patients suffering from resistant systemic lupus erythematosus can tolerate.

Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new generation of CAR-T cell therapy — where your own immune cells are reprogrammed in a lab to target two proteins (BCMA and CD19) — for people with severe, treatment-resistant systemic lupus erythematosus (SLE), a chronic autoimmune disease. **You may be eligible if...** - You are between 18 and 90 years old - You have been diagnosed with systemic lupus erythematosus (SLE) with a high disease activity score - Your lupus has not responded adequately to standard treatments - Your blood counts (red cells, white cells, platelets) and organ function (liver, kidneys, heart) meet minimum requirements - You are not pregnant (negative pregnancy test required for women of childbearing age) **You may NOT be eligible if...** - Your blood counts or organ function are too low - You have an active serious infection - You are pregnant or breastfeeding - You have a serious heart condition (heart pumping function below 50%) - You are unwilling to use contraception for at least one year after treatment Talk to your doctor to see if this trial is right for you.

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

BIOLOGICALCD19- 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.

Locations(1)

District One Hospital

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06350110

Related Trials

A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus

NCT06617325225 locations

A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease

NCT0630897818 locations