Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]
Conditions
Interventions
None listed
Sponsors
Tata Educational and Development Fund a Division of Tata Trusts Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of relapsed/refractory (R/R B-ALL) B-ALL patients between 5- 25 years of age who have circulating blasts in peripheral blood, which express CD19 moderate to bright positivity on flow Cytometry. 2. Any patient meeting these criteria will be screened, and those willing will be asked to consent for the study.
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
| Measure | Time frame |
|---|---|
| i.To complete pre-clinical development work on CAR T-cell construct at IIT-B, Powai. ii.To initiate the clinical grade manufacturing at cGMP facility of ACTREC and IIT- Bombay for anti CD19 CAR T cells.Timepoint: i.Feasibility study. May be terminated before study period (2 years) is over, if trial end-point of robust and effective CART-cell production achieved. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Validation of the GMP facility, CAR T-Cell Center. 2. Optimization of the manufacturing protocols for CAR T cells in a cGMP facility. 3. Standardization of the Release Testing Protocols and Sterility Assays for CAR T-cell manufacturing.Timepoint: Ongoing | — |
Countries
India
Contacts
Public ContactAlka Dwivedi
Tata Memorial Centre
Outcome results
None listed