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临床试验/NCT03389035
NCT03389035已完成1 期

Phase 1-2a Trial to Determine the Feasibility and Safety of a Single Dose of Transposon-manipulated Allogeneic CARCIK-CD19 Cells in Adult and Pediatric Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia, After Hematopoietic Stem Cell Transplantation

Fondazione Matilde Tettamanti Menotti De Marchi Onlus4 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2017年12月20日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
21
试验地点
4
主要终点
Dose Limiting Toxicities (DLT):

研究概览

简要总结

This is a single arm, open-label, multi-center, phase 1-2a study to determine the Maximum Tolerated Dose and/or the Recommended Phase 2 Dose and the safety of CARCIK-CD19 in adult and pediatric patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Year 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Children (1-17) and adults (18-75 years old);
  • Relapsed or refractory adult and pediatric B-cell precursor ALL after HSCT;
  • Evidence of CD19 tumor expression in bone marrow and/or peripheral blood by flow cytometry;
  • Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening;
  • No evidence of overall aGVHD > Grade I or chronic GVHD (cGVHD) greater than mild at time of enrollment and in the previous 30 days;
  • No longer taking immunosuppressive agents for at least 30 days prior to enrollment;

排除标准

  • Patients with GVHD Grades II-IV;
  • Any cell therapy in the last 30 days;

结局指标

主要结局

Dose Limiting Toxicities (DLT):

时间窗: 1 month

rate and severity of the cytokine release syndrome (CRS)

次要结局

未报告次要终点

研究者

发起方
Fondazione Matilde Tettamanti Menotti De Marchi Onlus
申办方类型
Other
责任方
Sponsor

研究点 (4)

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