The purpose of this clinical trial is to assess the feasibility, safety and efficacy of universal CAR T cells based on 4SCAR7U design against CD7-positive hematological malignancies using CD7 specific universal CAR T cells. The study also aims to learn more about the function of CD7 targeting CAR T cells and their persistence in patients of hematological malignancies.
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.
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.
Single group
Universal CD7-specific CAR gene-engineered T cells
Biological/VaccineInfusion of 4SCAR7U T cells
Safety of infusion
Treatment-related adverse events are assessed by NCI CTCAE V4.0 criteria.
Clinical response
Objective responses (complete response (CR) + partial response (PR)) are assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
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This trial is not recruiting at the moment. You can still explore other options:
