NCT03938987

A Phase 1b/2 Multi-center, De-centralized, Dose Selection Study of Autologous CD19-directed Chimeric Antigen Receptor (CAR) T-cells in Patients With Relapsed/Refractory Aggressive Lymphoma or Acute Lymphoblastic Leukemia (ALL)

Study Summary

Autologous, unselected CD3+ lymphocytes collected from 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).

Want to learn more about this trial?

Request More Info

Interventions

autologous CD19-directed chimeric antigen receptor (CAR) T-cellsBIOLOGICAL
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.

Study Locations

FacilityCityStateCountry
Foothills Medical CentreCalgaryAlbertaCanada
Tom Baker Cancer CentreCalgaryAlbertaCanada
Alberta Children's HospitalCalgaryAlbertaCanada
Cross Cancer InstituteEdmontonAlbertaCanada
Stollery Children's HospitalEdmontonAlbertaCanada
University of Alberta HospitalEdmontonAlbertaCanada

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026