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.
Who can participate
Age range6 Months – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.