JY231(JY231) Injection for the Treatment of R/R B-cell Malignancies

Официальное название

JY231 Injection for the Treatment of B-cell Malignancies Early Exploratory Clinical Studies on Safety, Tolerability, and Initial Efficacy

Обзор

This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory B-cell Malignancies. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed or refractory B-cell Malignancies.

Подробное описание

This is an open-label, single-arm study to evaluate the efficacy and safety of in vivo Chimeric Antigen Receptor T-Cell(CAR-T cell) therapy in patients with relapsed refractory B-cell Malignancies. Upon enrollment, subjects will receive an intravenous infusion of the JY231 preparation. Following the infusion, subjects will be hospitalized for one month for observation, and subjects will be evaluated for safety and efficacy. Subjects will be followed for up to 2 years to determine if the disease is under control.

Вмешательства

• Препарат JY231 Injection
  Patients were enrolled and given a single dose of JY231 injection intravenously, hospitalized for observation over the following month, and followed up for observation over the following 2 years.

Первичные конечные точки

• Maximal Tolerated Dose(MTD) [Срок оценки: Up to 28 days after infusion]
• Incidence of adverse events(AE) after infusion [Срок оценки: Day 28、Month 2、Month 3、Month 6、Month 12、Month 18、Month 24]

Вторичные конечные точки (1)

• Objective Response Rate [Срок оценки: Day 28、Month 2、Month 3、Month 6、Month 12、Month 18、Month 24]

Критерии участия

Критерии включения

• up to 75 years (Child, Adult) , either sex, sign informed consent (ICE);
• Histologically confirmed as B-cell Malignancies ;
• 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) ≥ 0.5 × 109/L, blood platelet(PLT)>30 × 109/L, Hb>80 g/L, with a single venous access and no other contraindications for blood cell separation;
• 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: NCT07065279 · JY-CT-25-008

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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