Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of B-cell acute lymphoblastic leukemia (B-ALL)
up to 75 years (Child, Adult) , either sex；
Bone marrow cell morphology examination showed the proportion of primitive and immature lymphocytes in the bone marrow is >5%, or the bone marrow MRD analysis comfirmed as B-ALL.
Flow cytometry or histology confirmed positive expression of cluster of differentiation 19 (CD19);
According to the researcher's assessment, the expected survival period is greater than 3 months;
Pregnant or lactating women, as well as women with pregnancy plans within six months;
Virological tests of hepatitis B, hepatitis C, AIDS, syphilis and cytomegalovirus were positive;
Having a history of other tumors (excluding skin or cervical carcinoma in situ cured by root therapy and without evidence of disease activity);
Previously received treatment targeting CD19;
Single group
JY231
Biological/VaccineInfusion of JY231 Injection by dose of 1-10×10\^6 Transduction Units (TU)/kg、1-5×10\^7 TU/kg、5-10 ×10\^7 TU/kg. Administration method: intravenous infusion、Splenic artery infusion、Lymph node infusion; Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion (PI evaluation is required)
Incidence of Treatment Related adverse events (AEs)
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
MTD
MTD will be determined based on DLTs observed during the first 28 days of study treatment.
Overall Response Rate (ORR)
Overall Response Rate (ORR) is defined as the proportion of subjects achieving complete remission (CR) and complete remission with incomplete hematological recovery (CRi).
Best Overall Response
The optimal degree of disease status improvement achieved by the patient over the course of the entire clinical trial or treatment period.
Duration of remission (DOR)
Duration of remission (DOR) is the time from the first detection of CR or PR to the discovery of PD.
Time To Progression (TTP)
The duration from the initiation of treatment until the first occurrence of objective disease progression.
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