JY231(JY231) Injection for the Treatment of R/R B-cell Malignancies
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. up to 75 years (Child, Adult) , either sex, sign informed consent (ICE); 2. Histologically confirmed as B-cell Malignancies ; 3. Flow cytometry or histology confirmed positive expression of cluster of differentiation 19(CD19); 4. According to the researcher's assessment, the expected survival period is greater than 3 months; 5. Eastern Cooperative Oncology Group(ECOG) physical condition score ≤ 3; 6. The patient has good liver, kidney, heart, and lung functions: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal(ULN), which can be relaxed to ≤ 5 × ULN for patients with liver invasion; Total serum bilirubin # 34 μ Mol/L; Creatinine clearance rate\>30 mL/min; Cardiac ejection fraction (EF) ≥ 40%, without pericardial effusion and significant arrhythmia; Indoor oxygen saturation(SpO2) ≥ 92%; 7. Peripheral blood lymphocyte absolute count: absolute lymphocyte count(ALC) ≥ 0.5 × 109/L, blood platelet(PLT)\>30 × 109/L, Hb\>8