CARPALL: Immunotherapy with CD19+CD22 CAR T-cells for CD19+ and CD22+ Acute Lymphoblastic Leukaemia

PHASE1RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

April 30, 2016

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2041

Conditions
Acute Lymphoblastic Leukemia
Interventions
PROCEDURE

Leukapheresis

Patients will undergo an unstimulated leukapheresis to isolate the required immune cells to produce the CD19+CD22 CAR T-cells

RADIATION

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.

DRUG

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.

DRUG

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.

BIOLOGICAL

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.

Trial Locations (3)

Unknown

RECRUITING

Great Ormond Street Hospital, London

RECRUITING

University College Hospital, London

RECRUITING

Manchester Royal Children's Hospital, Manchester

All Listed Sponsors
lead

University College, London

OTHER