Evaluation of Sup19 CAR-T cells in cases where previous CD19-targeted therapy has failed or where CD19 Evaluation of Safety and Efficacy in the Treatment of Low-Grade Hematological Malignancies: A Prospective, Single-Arm Clinical Study Research
Patients aged ≥18 and <70 years, of any gender;
diagnosed with B-ALL/LBL according to the criteria of the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2020.v1) and B-cell Lymphoma Clinical Practice Guidelines (2020.v1);
meeting either of the following two criteria: (1) Previous targeted CD19 therapy, including bispecific antibodies, ADC drugs, and CAR-T, with continued CD19 expression; (2) Patients with hematological malignancies who have not received CD19-targeted therapy in the past, with weakly positive CD19 expression;
At the time of screening, the number of blasts in the bone marrow is 25% (bone marrow morphology) and/or extramedullary lesions;
Acute promyelocytic leukemia (APL);
presence of hereditary syndromes such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known myelodysplastic syndrome;
uncontrolled active central nervous system leukemia (CNSL), i.e., cerebrospinal fluid (CSF) classification CNS 3;
prior administration of antineoplastic therapy before infusion; exclusion criteria include: a. Received systemic chemotherapy within 1 week (excluding pre-treatment); b. Those who have received monoclonal antibody treatment, with the time from the last monoclonal antibody infusion to the screening being less than 5 half-lives or 4 weeks (whichever is shorter); c. Received donor lymphocyte infusion (DLI) within 6 weeks;
Institute of Hematology & Blood Diseases Hospital, China
Lead sponsor