This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory B-cell Malignancies.
It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed or refractory B-cell Malignancies.
up to 75 years (Child, Adult) , either sex, sign informed consent (ICE);
Histologically confirmed as B-cell Malignancies ;
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 Injection
DrugPatients were enrolled and given a single dose of JY231 injection intravenously, hospitalized for observation over the following month, and followed up for observation over the following 2 years.
Maximal Tolerated Dose(MTD)
MTD will be determined based on Dose-Limiting Toxicity(DLTs) observed during the first 28 days of study treatment.
Incidence of adverse events(AE) after infusion
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
Objective Response Rate
Objective Response Rate(ORR) is defined as the proportion of subjects achieving complete remission(CR) and partial response(PR).
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