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临床试验/NCT03598179
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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

JianYong Li

Professor

The First Affiliated Hospital with Nanjing Medical University

研究点 (1)

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