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.
Single group
autologous CD19-directed chimeric antigen receptor (CAR) T-cells
Biological/VaccineAnti-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.
Number and type of treatment-related adverse events.
Number of dose limiting toxicities of anti-CD19 CAR T-cells
Maximum concentration (Cmax).
Time to maximum concentration (Tmax).
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University of Alberta
Lead sponsor
Alberta Cancer Foundation
Collaborator
Canadian Cancer Trials Group
Collaborator
