RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Subjects with acute myeloid leukemia who voluntarily signed willing to sign a consent form and met the following criteria: - Age older than 6 months. - Confirmed expression of CLL-1, CD123 and/or CD33 in blast AML by immuno-histochemical staining or flow cytometry. - Karnofsky performance status (KPS) score is higher than 80 and life expectancy \> 3 months. - Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5 × upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal, total bilirubin ≤ 2.0mg/dL. - Hgb≥80g/L. - No cell separation contraindications. - Abilities to understand and the willingness to provide written willing to sign a consent form. Who Should NOT Join This Trial: - Severe illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection. - Active bacterial, fungal or viral infection not controlled by adequate treatment. - Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. - Pregnant or nursing women may not participate. - Use of glucocorticoid for systemic therapy within one week prior to entering the trial. - Patients, in the opinion of investigators, may not be able to comply with the study. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Subjects with acute myeloid leukemia who voluntarily signed informed consent and met the following criteria: * Age older than 6 months. * Confirmed expression of CLL-1, CD123 and/or CD33 in blast AML by immuno-histochemical staining or flow cytometry. * Karnofsky performance status (KPS) score is higher than 80 and life expectancy \> 3 months. * Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5 × upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal, total bilirubin ≤ 2.0mg/dL. * Hgb≥80g/L. * No cell separation contraindications. * Abilities to understand and the willingness to provide written informed consent. Exclusion Criteria: * Severe illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection. * Active bacterial, fungal or viral infection not controlled by adequate treatment. * Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. * Pregnant or nursing women may not participate. * Use of glucocorticoid for systemic therapy within one week prior to entering the trial. * Patients, in the opinion of investigators, may not be able to comply with the study.

Treatments Being Tested

BIOLOGICAL

CD123/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