NCT07065279 JY231(JY231) Injection for the Treatment of R/R B-cell Malignancies

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 36 participants in total. It began in 2025-07 with a primary completion date of 2027-12.

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\>80 g/L, with a single venous access and no other contraindications for blood cell separation; 8. Individuals with fertility must agree to the use of efficient contraceptive methods; 9. The subject or their legal guardian can understand and voluntarily sign a written informed consent form. Exclusion Criteria: 1. Pregnant or lactating women, as well as women with pregnancy plans within six months; 2. Virological tests of hepatitis B, hepatitis C, AIDS, syphilis and cytomegalovirus were positive; 3. Having a history of other tumors (excluding skin or cervical carcinoma in situ cured by root therapy and without evidence of disease activity); 4. Previously received treatment targeting CD19; 5. Received autologous hematopoietic stem cell transplantation within 6 weeks; 6. The presence of uncontrollable active bacterial or fungal infections; 7. Allergies to research related drugs or cellular components; 8. Active autoimmune diseases exist; 9. Patients with unstable or active ulcers or gastrointestinal bleeding currently present; 10. Individuals with mental or psychological disorders who cannot cooperate with treatment and efficacy evaluation; 11. Received other experimental drug treatments within the past 3 months; 12. Existence of grade II-IV acute graft versus-host disease(GVHD) or widespread chronic GVHD; 13. Researchers believe that other reasons are not suitable for clinical trial participants.

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