Universal 4SCAR7U Targeting CD7-positive Malignancies
T-cell Acute Lymphoblastic Leukemia, T-cell Acute Lymphoblastic Lymphoma, Acute Myeloid Leukemia
About this trial
This is an interventional treatment trial for T-cell Acute Lymphoblastic Leukemia focused on measuring T-ALL, TCL, AML, NK lymphoma, Universal CAR T, CD7
Eligibility Criteria
Inclusion Criteria: Age older than 6 months. Confirmed expression of CD7 and additional surface antigens in the cancer cells 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: Sever 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 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. Previous treatment with any gene therapy products. Patients, in the opinion of investigators, may not be able to comply with the study.
Sites / Locations
- Shenzhen Geno-immune Medical InstituteRecruiting
Arms of the Study
Arm 1
Experimental
Universal 4SCAR7U cells to treat CD7-positive hematological malignancies