Study Summary
This study aims to evaluate the safety, efficacy and duration of response of CD19+CD22 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in children with high risk, relapsed CD19+ and CD22+ acute lymphoblastic leukaemia
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Request More InfoInterventions
LeukapheresisPROCEDURE
Patients will undergo an unstimulated leukapheresis to isolate the required immune cells to produce the CD19+CD22 CAR T-cells
Total Body Irradiation (TBI)RADIATION
Participants will receive total body irradiation delivered as a single fraction (2Gy) on day -7 prior to CD19+CD22CAR T-cell infusion.
Lymphodepletion with FludarabineDRUG
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 CyclophosphamideDRUG
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-cellsBIOLOGICAL
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.
Study Locations
| Facility | City | State | Country |
|---|---|---|---|
| Great Ormond Street Hospital | London | United Kingdom | |
| University College Hospital | London | United Kingdom | |
| Manchester Royal Children's Hospital | Manchester | United Kingdom |