CTRI/2016/12/007517
Not yet recruiting
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 sites20 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Pediatric patients with relapsed blood cancer
- Sponsor
- TMC Research Administration Council
- Enrollment
- 20
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •1\.Patients with CD19 negative leukemic cells of any degree will be excluded.
- •2\.Patients not consenting for the study
Outcomes
Primary Outcomes
Not specified
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