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临床试验/CTRI/2016/12/007517
CTRI/2016/12/007517尚未招募未知

A Preclinical Translational Study to Evaluate the Efficacy of scfv-CD28-CD3ζ CAR T-Cells Manufactured from Healthy Volunteers and Patients with Relapsed/ Refractory Acute Lymphoblastic Leukemia in ex-vivo Setting

TMC Research Administration Council0 个研究点目标入组 20 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
尚未招募
发起方
入组人数
20

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

入选标准

  • 1.Age- Patients under 25 years of age with medullary relapse B- ALL of any number who have not undergone SCT will be eligible for further screening for the study.
  • 2.Refractory B ALL in first line therapy will also be eligible if there is persistent MRD positivity of > 0.01% after 2 consecutive cycles of standard chemotherapy will also be eligible for screening.
  • This patient cohort is representative of those who might finally benefit from CAR therapy in future and it would be essential to demonstrate the capability to produce effective CAR T-cells from these patients.
  • 3.FCM records patients having CD19 positive B-ALL, and that no other CD19 negative clone was present at diagnosis or relapse/ refractory stage as established by FCM or cytogenetics, which would have already been done in these patients as per existing DMG operational policy.

排除标准

  • 1.Patients with CD19 negative leukemic cells of any degree will be excluded.
  • 2.Patients not consenting for the study

研究者

发起方
TMC Research Administration Council

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