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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2016/12/007517
• Date of registration: 01-12-2016
• Prospective Registration: Yes
• Primary sponsor: TMC Research Administration Council
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 01-12-2016
• Target sample size: 20
• Recruitment status: Not Yet Recruiting
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=16854
• Study type: Observational
• Study design: Single Arm Trial; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Dr Surg Cdr Gaurav Narula
• Affiliation: Tata Memorial Hospital

• Name: Dr Surg Cdr Gaurav Narula
• Affiliation: Tata Memorial Hospital

Key inclusion & exclusion 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



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Intervention1: Blood Sampling or Pharesis: Blood sample will be collected or pharesis will conducted after consenting once for further study conduct
Control Intervention1: NA: NA

Primary Outcome(s)

1.Demographic, clinical and hematological profiles of enrolled patients

2.CD3+ and Lymphocyte count yields in the apheresis bags and their correlation with baseline CD3+, blast and lymphocyte counts.

3.Transfection efficacy and CAR T-cell counts at Day-14 of production and expansion.

4.B-leukemia cell counts in cohorted cultured samples at Day-14.

5.Ex-vivo B-leukemia killing efficacy of CAR T-cells in culture

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(s)

NATimepoint: NA

Secondary ID(s)

NIL

Source(s) of Monetary Support

Tata Memorial Hospital. Dr. E Borges Road, Parel. Mumbai-400012

Ethics review

Status: Approved
Approval date: 21/11/2016
Contact:

Institutional Ethics Committee-II, Tata Memorial Hospital. Parel. Mumbai