Acute Myeloid Leukemia Clinical Trial
Official title:
Universal CAR T Cells for the Treatment of Acute Myeloid Leukemia
The purpose of this clinical trial is to assess the feasibility, safety and efficacy of universal CAR T-cell products targeting CLL-1, CD33, CD38 and CD123 in patients with relapsed and refractory AML. The study also aims to learn more about the function of the universal CAR T cells and their persistency in AML patients.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 31, 2026 |
Est. primary completion date | September 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 75 Years |
Eligibility | Inclusion Criteria: 1. Age older than 6 months. 2. Confirmed expression of CLL-1, CD123, CD38 and/or CD33 in AML blasts by immuno-histochemical staining or flow cytometry. 3. Karnofsky performance status (KPS) score is higher than 80 and life expectancy > 3 months. 4. 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. 5. Hgb=80g/L. 6. No cell separation contraindications. 7. Abilities to understand and the willingness to provide written informed consent. Exclusion Criteria: 1. Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection. 2. Active bacterial, fungal or viral infection not controlled by adequate treatment. 3. Known HIV or active hepatitis C virus (HCV) infection. 4. Pregnant or nursing women may not participate. 5. Use of glucocorticoid for systemic therapy within one week prior to entering the trial. 6. Previous treatment with any gene therapy products. 7. The bone marrow AML burden (MRD) is above 50%. 8. Patients, in the opinion of investigators, may not be able to comply with the study. |
Country | Name | City | State |
---|---|---|---|
China | Shenzhen Geno-Immune Medical Institute | Shenzhen | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Shenzhen Geno-Immune Medical Institute |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety of infusion | Treatment-related adverse events are assessed by NCI CTCAE V4.0 criteria. | 6 months | |
Secondary | Clinical response | Objective responses (complete response (CR) + partial response (PR)) are assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. | 1 year |
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