RecruitingPhase 1Phase 2NCT06428188

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

Sponsor

Essen Biotech

Enrollment

60 participants

Start Date

May 29, 2024

Study Type

INTERVENTIONAL

Conditions

Systemic Lupus Erythematosus Sjogren's Syndrome Autoimmune Diseases Systemic Lupus Erythematosus Acute

Summary

This is an open, single-arm, clinical study to evaluate the efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) targeting BCMA or CD19 or both sequentially in the treatment of Relapsed/ Refractory Autoimmune Disease such as Sjogren's Syndrome or Systemic Lupus Erythematosus and other Autoimmune Disease.

Eligibility

Min Age: 21 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a type of advanced immune cell therapy called CAR-T cell therapy — which re-engineers a patient's own immune cells to target and destroy overactive immune cells — in people with severe autoimmune diseases that have not responded to standard treatments. The goal is to reset an overactive immune system. **You may be eligible if...** - You have a relapsed or treatment-resistant autoimmune disease such as lupus, inflammatory muscle disease, scleroderma, Sjogren's syndrome, rheumatoid arthritis, IgG4-related disease, autoimmune platelet disorder, or similar conditions - You have failed standard therapies or have no effective treatment options available - Your expected survival is at least 3 months - Your liver, kidney, and heart function are within acceptable ranges - You do not have serious mental illness **You may NOT be eligible if...** - You have a current or past (within 5 years) malignant (cancerous) tumor, with certain exceptions - You have active hepatitis B, hepatitis C, or HIV, or positive syphilis test - You have serious heart disease, including recent heart attack or severe heart failure - You are pregnant or breastfeeding, or planning pregnancy within 2 years - You have previously received CAR-T therapy or other gene-modified cell therapy - You have active, uncontrolled infection - You have signs of cancer spreading to the brain or nervous system 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.

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Interventions

BIOLOGICALBCMA/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.