RecruitingPhase 1Phase 2NCT06420063

Sequential CAR-T Cells Targeting CD33/CD123 in Patients With Acute Myelocytic Leukemia AML

Sequential CAR-T Cell Infusion Targeting CD33 and CD123 for Refractory/Relapsed Acute Myeloid Leukaemia


Sponsor

Essen Biotech

Enrollment

85 participants

Start Date

Jul 10, 2024

Study Type

INTERVENTIONAL

Conditions

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 CD33 or CD123 or both sequentially in the treatment of Acute Myelocytic Leukemia.


Eligibility

Min Age: 6 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a CAR-T cell therapy — a treatment where your own immune cells are engineered in a lab to target and kill leukemia cells — for people with acute myeloid leukemia (AML). The cells are designed to attack two specific proteins found on leukemia cells: CD33 and CD123. **You may be eligible if...** - You are at least 6 months old and have been diagnosed with AML - Your leukemia cells test positive for CLL-1, CD123, and/or CD33 - You are in reasonably good overall health (able to carry out normal activity) - Your heart, liver, and kidney function are within acceptable ranges - You are willing to participate and sign consent **You may NOT be eligible if...** - Your organs (heart, liver, kidneys) are not functioning well enough - You have conditions preventing the cell collection process - 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

BIOLOGICALCD123/CD33 CART

The intervention in this clinical trial involves a novel approach using CD22/123-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. CD33/123-Chimeric Antigen Receptor T Cells (Day 0): IV administration of investigational therapy, CD33/123-CAR T cells, over 10-20 minutes on day 0. Additional Doses: Eligible patients responding well to the initial CD33/123 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

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NCT06420063


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