Evaluation of CAR19 T-cells as an Optimal Bridge to Allogeneic Transplantation

PHASE1CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

June 30, 2016

Primary Completion Date

February 2, 2020

Study Completion Date

March 21, 2022

Conditions
Diffuse Large B-Cell Lymphoma
Interventions
PROCEDURE

Leukapheresis

Patients will undergo leukapheresis prior to pre-conditioning chemotherapy to provide the immune cells required to produce the therapeutic product.

DRUG

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).

DRUG

Fludarabine

Fludarabine 25mg/m2/day IV over 15/30 minutes for 5 days (Day-5 to day-1).

BIOLOGICAL

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"

Trial Locations (1)

Unknown

University College London Hospital, London

All Listed Sponsors
lead

University College, London

OTHER

NCT02431988 - Evaluation of CAR19 T-cells as an Optimal Bridge to Allogeneic Transplantation | Biotech Hunter | Biotech Hunter