To Observe the CD7-targeted CAR-T Therapy in the Treatment of MRD Positive T-ALL/LBL Post Allo-HSCT
Trial Parameters
Brief Summary
To observe the efficacy and safety of CD7-targeted chimeric antigen receptor T cells in the treatment of T-lymphoblastic leukaemia/lymphoma with postive measurable residual disease positive post allogeneic stem cell transplantation
Eligibility Criteria
Inclusion Criteria: * (1) The subject or the legal guardian understands and voluntarily signs the informed consent form (ICF). (2) Male or female, age ≥ 3 years at the time of signing the informed consent form. (3) Expected survival period of no less than 12 weeks. (4) ECOG performance score of 0-2 at the time of signing the ICF. (5) Confirmed as relapsed/refractory T-cell leukemia or lymphoma at the time of signing the ICF, meeting the following criteria: 1. Bone marrow morphology examination at screening shows the proportion of primitive immature lymphocytes in the bone marrow \< 5%, and positive for minimal residual disease of leukemia/lymphoma determined by flow cytometry. 2. Tumor cells in the bone marrow or peripheral blood are CD7 positive as detected by flow cytometry. (6) Major organ functions must meet the following requirements: <!-- --> 1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5× upper limit of normal (ULN). 2. Total bilirubin ≤ 2× ULN. 3. Fo