JY231 (JY231) Injection for the Treatment of B-cell Acute Lymphoblastic Leukemia (B-ALL)

NCT ID: NCT06514768

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-20
• Study Completion Date: 2026-06-30

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)

Conditions

B-cell Acute Lymphoblastic Leukemia (B-ALL)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JY231 injection for the treatment of B-cell acute lymphoblastic leukemia (B-ALL)

Group Type: EXPERIMENTAL

JY231

Intervention Type: BIOLOGICAL

Infusion of JY231 Injection by dose of 1-10×10\^6 Transduction Units (TU)/kg、1-5×10\^7 TU/kg、5-10 ×10\^7 TU/kg. Administration method: intravenous infusion、Splenic artery infusion、Lymph node infusion; Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion (PI evaluation is required)

Interventions

JY231

Infusion of JY231 Injection by dose of 1-10×10\^6 Transduction Units (TU)/kg、1-5×10\^7 TU/kg、5-10 ×10\^7 TU/kg. Administration method: intravenous infusion、Splenic artery infusion、Lymph node infusion; Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion (PI evaluation is required)

Intervention Type: BIOLOGICAL

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.

• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sanbin Wang

Role: PRINCIPAL_INVESTIGATOR

920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

Locations

920th HJointLogistics

Kunming, Yunnan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Sanbin Wang, Doctor

Role: CONTACT

sanbin1011@163.com

13187424131 ext. +86

Other Identifiers

JY-CT-23-006

Identifier Type: -

Identifier Source: org_study_id