JY231(JY231) Injection for the Treatment of R/R B-cell Malignancies

Prior treatment

• Previously received treatment targeting CD19;
• Received autologous hematopoietic stem cell transplantation within 6 weeks;
• Received other experimental drug treatments within the past 3 months;

Other illness

• 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);
• The presence of uncontrollable active bacterial or fungal infections;
• Allergies to research related drugs or cellular components;
• Active autoimmune diseases exist;
• Patients with unstable or active ulcers or gastrointestinal bleeding currently present;
• Individuals with mental or psychological disorders who cannot cooperate with treatment and efficacy evaluation;
• Existence of grade II-IV acute graft versus-host disease(GVHD) or widespread chronic GVHD;

Other

• Pregnant or lactating women, as well as women with pregnancy plans within six months;
• Researchers believe that other reasons are not suitable for clinical trial participants.

• 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;
• Eastern Cooperative Oncology Group(ECOG) physical condition score ≤ 3;
• 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%;
• Peripheral blood lymphocyte absolute count: absolute lymphocyte count(ALC) ≥ 0.5 × 109/L, blood platelet(PLT)\>30 × 109/L, Hb\>80 g/L, with a single venous access and no other contraindications for blood cell separation;
• Individuals with fertility must agree to the use of efficient contraceptive methods;
• The subject or their legal guardian can understand and voluntarily sign a written informed consent form.