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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2016/12/007517
Enrollment
20
Registered
2016-12-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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

Sponsors

TMC Research Administration Council
Lead Sponsor

Eligibility

Inclusion 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

Exclusion criteria: 1.Patients with CD19 negative leukemic cells of any degree will be excluded. 2.Patients not consenting for the study

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
NATimepoint: NA—

Countries

India

Contacts

Public ContactDr Surg Cdr Gaurav Narula

Tata Memorial Hospital

drgauravnarula@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026