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Clinical Trials/CTRI/2016/12/007517
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Observational

Investigators

Sponsor
TMC Research Administration Council

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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