NCT05639179招募中1 期
An Investigator-initiated Trial to Evaluate the Efficacy and Safety of Anti-CD19 Universal CAR-T Cells in the Treatment of Relapsed/Refractory(r/r) CD19+ B-cell Acute Lymphoblastic Leukemia(B-ALL)
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 30 人开始时间: 2022年12月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity (DLT)
研究概览
简要总结
This is a single-arm, single-center, open-labeled clinical study to evaluate the safety and efficacy of UCAR-T Cells injection for patients with relapsed/refractory(r/r) B-cell Acute Lymphoblastic Leukemia(B-ALL).
详细描述
Although the anti-CD19 CAR-T cell therapies have gained significant clinical outcome in patients with r/r B-ALL，autologous CAR-T is not feasible for some patients. To make further improvement, the investigators are going to conduct a clinical trial using universal CAR-T(UCAR-T) cells targeting CD19 for r/r B-ALL patients.
After enrollment, patients will get a 3-5 days lymphodepletion therapy, then the UCAR-T Cells will be infused by vein. Subjects will be followed for safety and efficacy up to 12 weeks. For those with a durable remission 12 weeks after infusion, the follow-up will last for at least 12 months for disease 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
- •Male or female, aged 2-75 years;
- •A definite diagnosis of relapsed/refractory B-ALL and a percentage of primitive/naive lymphocytes >5% in bone marrow at baseline (flow cytometry);
- •CD19 expression was positive in bone marrow or peripheral blood tumor cells;
- •ECOG score 0-2 points;
- •Expected survival time ≥3 months;
- •Adequate liver, kidney, heart and lung function;
- •Patients who have recovered from acute toxic effects of prior chemotherapy should be excluded from the trial at least one week apart;
- •Women of childbearing age have negative blood pregnancy test before the start of the trial, and agree to take effective contraceptive measures during the trial until the last follow-up; male subjects with partners of childbearing potential agree to take effective contraceptive measures during the trial until the last follow-up;
- •Voluntarily sign the informed consent.
排除标准
- •Presence of other concurrent active malignancy;
- •People with severe mental disorders;
- •A history of any of the following genetic disorders, such as Fanconi anemia, Schu-Day syndrome, Gerstmann syndrome, or any other known bone marrow failure syndrome;
- •Acute GVHD of grade II-IV or extensive chronic GVHD;
- •Had grade III-IV heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other clinically prominent heart disease within one year prior to enrollment;
- •The presence of any indwelling catheter or drainage (e.g., percutaneous nephrostomy, indwelling catheter, bile drainage, or pleural/peritoneal/pericardial catheter), except for patients who are permitted to use dedicated central venous catheters;
- •A history or disease of the central nervous system(CNS), such as seizure disease, cerebrovascular ischemia/bleeding, dementia, cerebellar disease, or any autoimmune disease involving the CNS;
- •Human immunodeficiency virus (HIV) seropositivity; Hepatitis B surface antigen positive or hepatitis B core antibody positive, and HBV-DNA positive; Patients with hepatitis C (HCV-RNA quantitative test results positive); Or the presence of other serious active viral or bacterial infections or uncontrolled systemic fungal infections;
- •Patients with severe history of allergy or allergic constitution;
- •A history of autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) leading to end-organ damage or requiring systemic immunosuppressive/systemic disease modulating drugs within the past 2 years;
- •Had or is suffering from interstitial lung disease (e.g., pneumonia, pulmonary fibrosis);
- •Had undergone other clinical trials in the 4 weeks prior to participating in this trial;
- •Poor compliance due to physiological, family, social, geographical and other factors, unable to cooperate with the study protocol and follow-up plan;
- •For patients contraindicated with cyclophosphamide and fludarabine chemotherapy;
- •Subjects requiring systemic corticosteroid therapy (prednisone ≥5mg/ day or equivalent dose of another corticosteroid) or other immunosuppressive agents within 1 month after UCAR-T cell reinfusion, except for adverse events;
- •Receiving donor lymphocyte infusion within 6 weeks before enrollment;
- •Pregnant and lactating women;
- •Any other condition that the investigator deemed inappropriate for inclusion.
结局指标
主要结局
Dose-limiting toxicity (DLT)
时间窗: Up to 28 days after infusion
Neurotoxicity and/or CRS≥G3.
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.
次要结局
- Duration of remission (DOR)(Up to 24 weeks after infusion)
- Persistence of CAR-T cells(Up to 24 weeks after infusion)
- Objective response rate (ORR)(At 4,8,12 weeks after infusion)
- Progression-free survival (PFS)(Up to 24 weeks after infusion)
- Overall survival (OS)(Up to 24 weeks after infusion)
研究者
研究点 (1)
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