Anti-CD19, Dual Co-stimulatory (4-1BB, CD3ζ) Chimeric Antigen Receptor T-cells in Patients With Relapsed/Refractory Aggressive Lymphoma or Acute Lymphoblastic Leukemia (ALL)

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

March 3, 2021

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2027

Conditions
Relapsed Non Hodgkin LymphomaRelapsed Adult ALLRelapsed Pediatric ALL
Interventions
BIOLOGICAL

autologous CD19-directed chimeric antigen receptor (CAR) T-cells

Anti-CD19/4-1BB/CD3ζ CAR T-cell: autologous, unselected CD3+ lymphocytes collected from whole blood or apheresis, transfected with a lentiviral vector containing a 2nd generation chimeric antigen receptor (CAR) consisting of a scFv recognizing CD19 and dual co-stimulatory intracellular signaling domains (4-1BB and CD3ζ). All patients will receive lymphodepleting, conditioning chemotherapy in the form of cyclophosphamide (500 mg/m2/day) and fludarabine (30 mg/m2/day) on Days -5, -4, and -3 prior to a CAR T-cell intravenous, single dose administration on Day 0.

Trial Locations (6)

T2N2T9

NOT_YET_RECRUITING

Foothills Medical Centre, Calgary

T2N4N2

NOT_YET_RECRUITING

Tom Baker Cancer Centre, Calgary

T3B6A8

NOT_YET_RECRUITING

Alberta Children's Hospital, Calgary

T6G1Z2

RECRUITING

Cross Cancer Institute, Edmonton

T6G2B7

NOT_YET_RECRUITING

Stollery Children's Hospital, Edmonton

RECRUITING

University of Alberta Hospital, Edmonton

All Listed Sponsors
collaborator

Alberta Cancer Foundation

OTHER

collaborator

Canadian Cancer Trials Group

NETWORK

lead

University of Alberta

OTHER