10
Participants
Start Date
June 30, 2016
Primary Completion Date
February 2, 2020
Study Completion Date
March 21, 2022
Leukapheresis
Patients will undergo leukapheresis prior to pre-conditioning chemotherapy to provide the immune cells required to produce the therapeutic product.
Cyclophosphamide
Patients will receive a standard pre-conditioning regime with cyclophosphamide 60mg/kg/day IV over 1 hour for 2 days (day-7 and day-6).
Fludarabine
Fludarabine 25mg/m2/day IV over 15/30 minutes for 5 days (Day-5 to day-1).
CAR19 T-Cells
"The CAR19 T-cells are to be administered on day 0 at the dose specified by the Cancer Trials Centre (CTC) at the time of registration.~Three dose cohorts are planned:~* Dose Level 1: 2x105 CAR19 T-cells/kg~* Dose Level 2: 1x106 CAR19 T-cells/kg~* Dose Level 3: 5x106 CAR19 T-cells/kg"
University College London Hospital, London
University College, London
OTHER