50
Participants
Start Date
April 30, 2016
Primary Completion Date
December 31, 2026
Study Completion Date
December 31, 2041
Leukapheresis
Patients will undergo an unstimulated leukapheresis to isolate the required immune cells to produce the CD19+CD22 CAR T-cells
Total Body Irradiation (TBI)
Participants will receive total body irradiation delivered as a single fraction (2Gy) on day -7 prior to CD19+CD22CAR T-cell infusion.
Lymphodepletion with Fludarabine
Patients will receive lymphodepleting chemotherapy with iv fludarabine 30 mg/m2 on days -6 to -3 prior to CD19+CD22CAR T-cell infusion.
Lymphodepletion with Cyclophosphamide
Patients will receive lymphodepleting chemotherapy with iv cyclophosphamide 0.5 g/m2 on days -6 to -5 prior to CD19+CD22CAR T-cell infusion.
CD19+CD22 CAR T-cells
Dose level 1: 2 doses of 4 x 10\^5 CD19+CD22 CAR T-cells/kg Dose level 2: 2 doses of 1 x 10\^6 CD19+CD22 CAR T-cells/kg given as a split dose as an intravenous injection through a Hickman line or PICC line (peripherally inserted central catheter) on day 0 and day 14.
RECRUITING
Great Ormond Street Hospital, London
RECRUITING
University College Hospital, London
RECRUITING
Manchester Royal Children's Hospital, Manchester
University College, London
OTHER