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临床试验/NCT02667093
NCT02667093Unknown不适用

Bone Marrow and Peripheral Blood (PB) Samples From Patients With Leukemia and PB From Their BM Donors (BMD) to Identify Leukemia-Specific Antigens (LSA) and Graft Versus Host Disease Antigens (GVHDA) for Use in Cellular Immunotherapy

PersImmune, Inc2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
Genomics of patients with leukemia and their HLA matched bone marrow transplant donors.

研究概览

简要总结

The purpose of this project is to develop a process to identify highly personalized antigens that are uniquely expressed by the patient's own leukemia cells that can be used for cellular immune therapy.

详细描述

It is well known that tumor cells and leukemia cells express different surface structures (called antigens) that can serve as targets for cancer cell destruction by the immune system. Effective immune therapies are characterized by high specificity and low toxicity. One of the major obstacles impeding the use of these therapies as standard of care is the identification of good target antigens. In acute myeloid leukemia (AML) there is major patient to patient variation in leukemia antigens, so there is no universal AML cell target. Rather, each patient has a unique array of potential cell targets. Thanks to the rapid progress of new DNA/RNA sequencing technologies, the identification of these unique, patient-specific leukemia cell antigen-targets is now possible.

The purpose of this project is to develop a process to identify highly personalized antigens that are uniquely expressed by the patient's own leukemia cells that can be used for cellular immune therapy.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Diagnosis of AML with plan to receive a bone marrow transplant

排除标准

  • 未提供

结局指标

主要结局

Genomics of patients with leukemia and their HLA matched bone marrow transplant donors.

时间窗: 5 years

To sequence the exome and transcriptome obtained from leukemia cells and the exome from their lymphocytes, and the lymphocytes from their HLA matched marrow transplant donors.

次要结局

  • Identification of patients' leukemia cell mutations and polymorphisms that are different from their HLA matched bone marrow transplant donors(5 years)
  • Peptide immunogenicity confirmation and donor T cell stimulation(5 years)
  • Data analysis and interpretation(5 years)
  • Immunogenic mutant neoantigen peptide selection(5 years)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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