Acute Myeloid Leukemia Clinical Trial
Official title:
Multi-center Phase I/II Clinical Trial of Multiple CAR T Cells for Treating Acute Myeloid Leukemia
The purpose of this clinical trial is to assess the feasibility, safety and efficacy of multiple CAR T-cell therapy which combines CAR T cells against CLL-1 with CAR T cells targeting CD123 or CD33 in patients with relapsed and refractory AML. The study also aims to learn more about the function of CAR T cells and their persistency in AML patients.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | December 31, 2023 |
Est. primary completion date | July 31, 2021 |
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 and/or CD33 in blast AML 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, hepatitis B virus (HBV) or 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. 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. | 1 year | |
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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