JY231(JY231) Injection for the Treatment of R/R B-cell Malignancies
Recruiting now · Not applicable
Conditions studied: B-cell Malignancies
In brief
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.
Key facts
- Study ID
- NCT07065279
- Run by
- 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
- People needed
- 36
- Starts
- 2025-07-01
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2025-07-15
Who can join
Age: 2 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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;
- Received autologous hematopoietic stem cell transplantation within 6 weeks;
- 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;
- Received other experimental drug treatments within the past 3 months;
- Existence of grade II-IV acute graft versus-host disease(GVHD) or widespread chronic GVHD;
- Researchers believe that other reasons are not suitable for clinical trial participants.
Where it is running
- 920th HJointLogistics — Kunming, Yunnan, China (enrolling)
Full record on ClinicalTrials.gov
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