Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Alberta Cancer Foundation | OTHER |
| Canadian Cancer Trials Group | NETWORK |
Not provided
Not provided
Not provided
Not provided
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).
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/m^2/day) on Days -5, -4, and -3 prior to a CAR T-cell intravenous, single dose administration on Day 0.
Phase 1b: Dose Finding/Escalation Dose Level 1: 0.5 x 10^6/kg Dose Level 2: 1.0 x 10^6/kg Dose Level 3: 2.0 x 10^6/kg
Phase 2: Expansion Patients will receive lymphodepleting chemotherapy as indicated prior to receiving the CAR T-cell intravenous, single dose administration on Day 0 at the RP2D as identified during Phase 1b.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAR T cells | Experimental | Patients with relapsed/refractory B-cell ALL or NHL. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous CD19-directed chimeric antigen receptor (CAR) T-cells | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number and type of treatment-related adverse events. | 3 years | |
| Number of dose limiting toxicities of anti-CD19 CAR T-cells | 3 years | |
| Maximum concentration (Cmax). | 3 years | |
| Time to maximum concentration (Tmax). | 3 years | |
| Area-Under-the-Concentration-vs-time curve (AUC) in peripheral blood and/or bone marrow. | 3 years | |
| Overall objective response rate (ORR: proportion of patients with confirmed responses of complete [CR] or partial [PR]) | 3 years |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zack Breckenridge | Contact | 7803917687 | zackariah.breckenridge@ahs.ca |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Michael P Chu, MD | Cross Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre | Not yet recruiting | Calgary | Alberta | T2N2T9 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
All enrolled patients will be included in the safety and PK analyses. All patients receiving the dose and schedule selected for expansion will be included in the efficacy and futility analyses including patients who received the selected dose and schedule in the phase 1b dose selection and dose escalation. Analysis of during phase 2 will occur using a Simon 2-stage design.
Not provided
Not provided
Not provided
Not provided
|
| Tom Baker Cancer Centre | Not yet recruiting | Calgary | Alberta | T2N4N2 | Canada |
|
| Alberta Children's Hospital | Not yet recruiting | Calgary | Alberta | T3B6A8 | Canada |
|
| Cross Cancer Institute | Recruiting | Edmonton | Alberta | T6G1Z2 | Canada |
|
| Stollery Children's Hospital | Not yet recruiting | Edmonton | Alberta | T6G2B7 | Canada |
|
| University of Alberta Hospital | Recruiting | Edmonton | Alberta | T6G2B7 | Canada |
|
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001336 | Automobiles |
| ID | Term |
|---|---|
| D018986 | Motor Vehicles |
| D014186 | Transportation |
| D013676 | Technology, Industry, and Agriculture |
Not provided
Not provided