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

NCT06514768 | Recruiting Early Phase 1

• 1 other identifier: JY-CT-23-006
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment Related adverse events (AEs)

  The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.

  Up to 12 months after infusion

• MTD

  MTD will be determined based on DLTs observed during the first 28 days of study treatment.

  Up to 28 days after infusion

Secondary Outcomes (6)

• Overall Response Rate (ORR)

  At 2,4,8 and 12 weeks after infusion

• Best Overall Response

  Up to 24 weeks after infusion

• Duration of remission (DOR)

  Up to 2 years after infusion

• Time To Progression (TTP)

  Up to 2 years after infusion

• Progression-free survival (PFS)

  Up to 2 years after infusion

Study Arms (1)

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

EXPERIMENTAL

Biological: JY231

Interventions

JY231 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)

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

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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.

Sponsors & Collaborators

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

Study Sites (1)

920th HJointLogistics

Kunming, Yunnan, China

RECRUITING

MeSH Terms

Conditions

Burkitt Lymphoma

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Sanbin Wang

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanbin Wang, Doctor

CONTACT

13187424131; sanbin1011@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 23, 2024
• Study Start: June 20, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-12

Locations

CN (1)