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Recruiting NCT06514768

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

Early Phase I Interventional B-cell Acute Lymphoblastic Leukemia (B-ALL)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JY231.
Who it may be relevant to
Registry conditions: B-cell Acute Lymphoblastic Leukemia (B-ALL). Basic parameters: up to 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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)

Interventions

  • Biological 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)

Primary outcome measures

  • Incidence of Treatment Related adverse events (AEs) [Time frame: Up to 12 months after infusion]
  • MTD [Time frame: Up to 28 days after infusion]
Secondary outcome measures (6)
  • Overall Response Rate (ORR) [Time frame: At 2,4,8 and 12 weeks after infusion]
  • Best Overall Response [Time frame: Up to 24 weeks after infusion]
  • Duration of remission (DOR) [Time frame: Up to 2 years after infusion]
  • Time To Progression (TTP) [Time frame: Up to 2 years after infusion]
  • Progression-free survival (PFS) [Time frame: Up to 2 years after infusion]
  • Overall survival (OS) [Time frame: Up to 2 years after infusion]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • 920th HJointLogistics — Kunming

Identifiers

NCT: NCT06514768 · JY-CT-23-006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗