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
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