JY231 injection for treating B-cell acute lymphoblastic leukemia

Early Exploratory Clinical Study on the Safety, Tolerability and Preliminary Efficacy of JY231 Injection in the Treatment of Acute B Lymphoblastic Leukemia

This study is testing a new injection called JY231 to see if it can safely help people with B-cell acute lymphoblastic leukemia feel better.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: N/A to 75 Years
• Sex: All
• Sponsor: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China (Academic / other)
• Locations: 1 site (Kunming, Yunnan)
• Trial ID: NCT06514768 on ClinicalTrials.gov

What this trial studies

This early-phase clinical trial evaluates the safety, tolerability, and initial efficacy of JY231 injection in patients diagnosed with B-cell acute lymphoblastic leukemia (B-ALL). Participants will receive the JY231 treatment, and their responses will be monitored to assess the drug's effectiveness and safety profile. The study aims to gather preliminary data that could inform further development of this treatment option for B-ALL. The trial includes patients up to 75 years old who meet specific health criteria.

Who should consider this trial

Good fit: Ideal candidates are individuals up to 75 years old with histologically confirmed B-cell ALL and specific health criteria.

Not a fit: Patients with severe comorbidities or those whose expected survival is less than three months may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with B-cell acute lymphoblastic leukemia.

How similar studies have performed: While this approach is exploratory, similar studies targeting B-ALL have shown promise in the past, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. up to 75 years (Child, Adult) , either sex；
2. 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.
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) ≥ 0.5E9/L, blood platelet (PLT) \> 30E9/L, Hb \> 80g/L, with a single venous access and no other contraindications for blood cell separation;
8. MRI examination showed no active malignant cells in the cerebrospinal fluid, no brain metastases, or no central nervous system leukemia;
9. Individuals with fertility must agree to the use of efficient contraceptive methods;
10. 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.

Where this trial is running

Kunming, Yunnan

• 920th HJointLogistics — Kunming, Yunnan, China (Recruiting)

Study contacts

• Principal investigator: Sanbin Wang — 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
• Study coordinator: Sanbin Wang, Doctor

Conditions B-cell Acute Lymphoblastic Leukemia