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;
Single group
Sup19 CAR-T
Biological/VaccineThe use of Sup19 CAR-T cells to treat hematologic malignancies with prior CD19-targeted therapy failure or CD19 weak expression aims to improve the relapse-free survival rate in patients with hematologic malignancies, providing a novel curative strategy for these patients.
Safety evaluation of Sup19 CAR-T cell therapy in patients with hematologic malignancies who have failed prior CD19-targeted therapy or exhibit weak CD19 expression: dose-limiting toxicity (DLT) adverse events (with particular focus on CRS and ICANS)
The best response rate of Sup19 CAR-T cell therapy within 3 months(The proportion of patients achieving CR/CRi)
Duration of response (DOR)
Event-free Survival, (EFS）
Leukemia-free Survival, (LFS）
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