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).
Have given written informed consent prior to any study-specific procedures; children (defined as 17 years of age or less) require guardian consent.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; or Karnofsky > 50%.
Age of 2 to 70 years at time of screening.
A histologically or cytologically documented, CD19+ non-hodgkin's lymphoma or ALL.
Prior treatment with immunotherapy directly targeting T-cells (except anti-thymocyte globulin [ATG]), CD19-directed antibody-based therapies (except blinatumomab), or other gene therapy products.
Received any investigational drug/anti-cancer therapy within 30 days.
Concurrent participation in another therapeutic clinical trial.
Therapeutic doses of corticosteroids (defined as > 20 mg/day prednisone or equivalent) within 7 days prior to blood collection for CAR T-cell product manufacture.
University of Alberta
Lead sponsor
Alberta Cancer Foundation
Collaborator
Canadian Cancer Trials Group
Collaborator