NCT03598179Unknown2 期
A Single-center, Open Study Evaluating Efficacy and Safety of XLCART001（CD-19） Treatment in Relapsed/Refractory/High-risk B-cell Malignancy Subjects
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年6月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
The trial is a single arm, single-center, non-randomized clinical trial which is designed to evaluate the efficacy and safety of XLCART001 in treatment of relapsed/refractory/high-risk B-cell malignancy subjects
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years, male and female,
- •Confirmed as CD19-positive B cell lymphoma/leukemia by immunohistochemistry or flow cytometry
- •No effective treatment
- •Patients must have a measurable or evaluable disease at the time of enrollment.
- •Adequate organ system function including:
- •ALT/AST < 3 upper limit of normal; Total Bilirubin < 2.5 upper limit of normal
- •Creatinine < 2 upper limit of normal
- •Oxygen saturation ≥ 95%
- •Left ventricular ejection fraction ≥ 40%
- •Number of neutrophil ≥ 0.75×10^9/L, number of platelet ≥ 50×10^9/L
- •At least 4 weeks from receiving previous treatment (radiotherapy, chemotherapy, monoclonal antibody therapy or other treatments)
- •No contraindications of peripheral blood apheresis
- •Female subjects in childbearing age, their serum or urine pregnancy test must be negative. All patients must agree to take effective contraceptive measures during the trial measures
- •ECOG score 0-2, expected survival ≥ 12 weeks
排除标准
- •Women who are pregnant or lactating. Patients have breeding intent in 12 months or cannot take effective contraceptive measures during the trial measures
- •Uncontrollable active infection within four week. Prophylactic antibiotic, antiviral and antifungal treatment is permissible. Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV-infected persons
- •Subjects with any autoimmune disease or any immune deficiency disease
- •Have a history of allergy to antibodies or cellular products
- •Participated in any other clinical trial within four weeks
- •Used of systemic steroids within four weeks (using inhaled steroids or ≤ 20mg/d prednison are exceptions)
- •Have mental diseases
- •Have history of drug addiction
- •The investigators believe that any increase in the risk of the subject or interference with the results of the trial
结局指标
主要结局
Overall response rate
时间窗: 12 weeks
Overall response rate (ORR) = complete response (CR) rate + partial response (PR) rate, ORR will be assessed at weeks 12.
Overall Survival
时间窗: 6 months,1 year, 2 years
from the time of enrollment to death from any cause or the date of the last follow-up visit
Event-free Survival
时间窗: 12 weeks,6 months,1 year, 2 years
the time from enrollment to any events, or the date of the last follow-up visit
Progression-free Survival
时间窗: 12 weeks,6 months,1 year, 2 years
the time from enrollment to disease progression, death from any cause, or the date of the last follow-up visit
次要结局
- Duration of CAR-T cells(Day 1, Day 4, Day 7, Day 10, Day 14, Day 21, Day 28, 8 weeks, 12 weeks, 6 months, 1 years, 2 years)
- Number of CAR-T cells(Day 1, Day 4, Day 7, Day 10, Day 14, Day 21, Day 28, 8 weeks, 12 weeks, 6 months, 1 years, 2 years)
- Dose-limiting toxicity (DLT)(28 days)
研究者
JianYong Li
Professor
The First Affiliated Hospital with Nanjing Medical University
研究点 (1)
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