JY231 Injection for the Treatment of B-cell Malignancies Early Exploratory Clinical Studies on Safety, Tolerability, and Initial Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Maximal Tolerated Dose(MTD)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
JY231 injection for the treatment of r/r B-cell Malignancies Early exploratory clinicaltrial
A single-center, open, single arm study JY231 Injection for the treatment of relapsed or refractory B-cell Malignancies subjects who meet the inclusion criteria will receive a single intravenous injection of JY231, followed by regular observation and follow-up of the subject.
干预措施: JY231 Injection (Drug)
结局指标
主要结局
Maximal Tolerated Dose(MTD)
时间窗: Up to 28 days after infusion
MTD will be determined based on Dose-Limiting Toxicity(DLTs) observed during the first 28 days of study treatment.
Incidence of adverse events(AE) after infusion
时间窗: Day 28、Month 2、Month 3、Month 6、Month 12、Month 18、Month 24
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
次要结局
- Objective Response Rate(Day 28、Month 2、Month 3、Month 6、Month 12、Month 18、Month 24)