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

Официальное название

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

Обзор

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)

Вмешательства

• Биопрепарат 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)

Первичные конечные точки

• Incidence of Treatment Related adverse events (AEs) [Срок оценки: Up to 12 months after infusion]
• MTD [Срок оценки: Up to 28 days after infusion]

Вторичные конечные точки (6)

• Overall Response Rate (ORR) [Срок оценки: At 2,4,8 and 12 weeks after infusion]
• Best Overall Response [Срок оценки: Up to 24 weeks after infusion]
• Duration of remission (DOR) [Срок оценки: Up to 2 years after infusion]
• Time To Progression (TTP) [Срок оценки: Up to 2 years after infusion]
• Progression-free survival (PFS) [Срок оценки: Up to 2 years after infusion]
• Overall survival (OS) [Срок оценки: Up to 2 years after infusion]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• 920th HJointLogistics — Куньмин

Идентификаторы

NCT: NCT06514768 · JY-CT-23-006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗