NCT06514768招募中早期 1 期
Early Exploratory Clinical Study on the Safety, Tolerability and Preliminary Efficacy of JY231 Injection in the Treatment of Acute B Lymphoblastic Leukemia
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年6月20日最近更新:
干预措施
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of Treatment Related adverse events (AEs)
研究概览
简要总结
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)
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
- — 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；
- •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.
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 B-cell acute lymphoblastic leukemia (B-ALL)
Experimental
干预措施: JY231 (Biological)
结局指标
主要结局
Incidence of Treatment Related adverse events (AEs)
时间窗: Up to 12 months after infusion
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
MTD
时间窗: Up to 28 days after infusion
MTD will be determined based on DLTs observed during the first 28 days of study treatment.
次要结局
- 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)
- Overall survival (OS)(Up to 2 years after infusion)
研究者
研究点 (1)
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