Status:
RECRUITING
JY231 (JY231) Injection for the Treatment of B-cell Acute Lymphoblastic Leukemia (B-ALL)
Lead Sponsor:
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Conditions:
B-cell Acute Lymphoblastic Leukemia (B-ALL)
Eligibility:
All Genders
Up to 75 years
Phase:
EARLY_PHASE1
Brief Summary
Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of B-cell acute lymphoblastic leukemia (B-ALL)
Eligibility Criteria
Inclusion
- up to 75 years (Child, Adult) , either sex；
- Bone marrow cell morphology examination showed the proportion of primitive and immature lymphocytes in the bone marrow is \>5%, or the bone marrow MRD analysis comfirmed as B-ALL.
- 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) ≥ 0.5E9/L, blood platelet (PLT) \> 30E9/L, Hb \> 80g/L, with a single venous access and no other contraindications for blood cell separation;
- MRI examination showed no active malignant cells in the cerebrospinal fluid, no brain metastases, or no central nervous system leukemia;
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06514768
Start Date
June 20 2024
End Date
June 30 2026
Last Update
January 6 2026
Active Locations (1)
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1
920th HJointLogistics
Kunming, Yunnan, China