A study conducted in outside human body to evaluate the Efficacy of a type of Cells Manufactured from Healthy Volunteers and Patients with Relapsed/ Refractory Acute Lymphoblastic Leukemia (a type of blood cancer) in laboratory setting

Not Applicable

Conditions: Health Condition 1: null- Pediatric patients with relapsed blood cancer

Registration Number: CTRI/2016/12/007517

Lead Sponsor: TMC Research Administration Council

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 20

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

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Demographic, clinical and hematological profiles of enrolled patients <br/ ><br>2.CD3+ and Lymphocyte count yields in the apheresis bags and their correlation with baseline CD3+, blast and lymphocyte counts. <br/ ><br>3.Transfection efficacy and CAR T-cell counts at Day-14 of production and expansion. <br/ ><br>4.B-leukemia cell counts in cohorted cultured samples at Day-14. <br/ ><br>5.Ex-vivo B-leukemia killing efficacy of CAR T-cells in culture <br/ ><br>6.CD19 receptor expression on manufactured CAR T cellsTimepoint: Baseline, Day-14 of production and expansion for T cells and for B cells

Secondary Outcome Measures