T Cells Expressing a Fully-human AntiCD19 Chimeric Antigen Receptor for Treating B-cell Malignancies

PHASE1CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

January 21, 2016

Primary Completion Date

June 12, 2018

Study Completion Date

December 31, 2022

Conditions
Lymphoma, B-CellLymphoma, Non-hodgkins
Interventions
BIOLOGICAL

Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells

Dose-escalation trial starting dose: 0.66x10\^6 CAR+ T cells/kg(weight based dosing)(up to a maximum dose of 18x10\^6 CAR+ T cells/kg) infuse on day 0

DRUG

Cyclophosphamide

300 mg/m\^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3

DRUG

Fludarabine

30 mg/m\^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4,and -3

Trial Locations (1)

20892

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH

NCT02659943 - T Cells Expressing a Fully-human AntiCD19 Chimeric Antigen Receptor for Treating B-cell Malignancies | Biotech Hunter | Biotech Hunter