RecruitingPhase 1Phase 2NCT06420076

Sequential CAR-T Cells Therapy for CD5/CD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD5/CD7-Specific CAR-T Cells

This is an Open, Single-arm, Clinical Study to Evaluate the Efficacy and Safety of Anti-CD7/CD5 CAR-T Cells in the Treatment of Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL), ETP-ALL, and Lymphoblastic Lymphoma (TLBL).

Sponsor

Essen Biotech

Enrollment

60 participants

Start Date

Jul 10, 2024

Study Type

INTERVENTIONAL

Conditions

T-cell Lymphoma T-cell Prolymphocytic Leukemia T-cell Acute Lymphoblastic Leukemia T-cell Leukemia T-Cell Lymphoma of CNS T Cell Childhood ALL

Summary

Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. Besides CD19, many other molecules such as CD22, CD30,BCMA,CD123, etc. may be the potential to develop the corresponding CAR-T cells to treat patients whose tumors express those markers. In this study, investigators will evaluate the safety and efficacy of Sequential CAR-T Cells Targeting CD5/CD7 in patients with patients with relapsed or refractory T-ALL/LBL/ETP-ALL. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, disease status after treatment will also be evaluated.

Eligibility

Min Age: 2 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a CAR-T cell therapy for T-cell leukemia and lymphoma — cancers that are hard to treat because standard CAR-T approaches can accidentally destroy healthy immune cells. This therapy uses specially engineered cells targeting CD5 and CD7 proteins on leukemia cells. **You may be eligible if...** - You are between 2 and 60 years old - You have T-cell leukemia or lymphoma diagnosed using WHO criteria - Your leukemia hasn't responded to standard treatment, or it came back after remission - Your cancer cells test positive for CD7 or CD5 (at least 70%) - You are otherwise in reasonable health **You may NOT be eligible if...** - Your overall health is too poor to tolerate intensive treatment - You have severe liver or kidney problems - Your leukemia cells do not express CD7 or CD5 - You are pregnant or breastfeeding 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

BIOLOGICALCD5/CD7 CAR-T

The intervention in this clinical trial involves a novel approach using CD5/CD7 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. CD5/CD7 Chimeric Antigen Receptor T Cells (Day 0): IV administration of investigational therapy, CD5/CD7 CAR T cells, over 10-20 minutes on day 0. Additional Doses: Eligible patients responding well to the initial CD5/CD7 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

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NCT06420076

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