Anti-CD19, Dual Co-stimulatory (4-1BB, CD3ζ) Chimeric Antigen Receptor T-cells in Patients With R… (NCT03938987) | Clinical Trial Compass
RecruitingPhase 1/2
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)
Canada63 participantsStarted 2021-03-03
Plain-language 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).
Who can participate
Age range2 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. At least 1 measurable lesion or FDG-avid disease by positron-emission tomography/computed tomography (PET/CT) for lymphoma patients; quantifiable evidence of ALL in either peripheral blood or bone marrow aspirate.
✓. Tumor tissue (archival or recent acquisition) must be available for correlative laboratory studies (such as immunohistochemistry, and others).
✓. At least 2 prior systemic therapies and patient must not be eligible for potentially curative standard-of-care therapy.
✓. Adequate renal function (defined as Cockroft-Gault creatinine clearance \> 50 mL/min) and hepatic function (total bilirubin \< 1.5x ULN; and AST/ALT \< 3x ULN) unless directly related to malignant disease being treated for on study as demonstrated either by PET/CT imaging or by biopsy and histopathologic confirmation.
Exclusion criteria
✕. 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.
✕
What they're measuring
1
Number and type of treatment-related adverse events.
Timeframe: 3 years
2
Number of dose limiting toxicities of anti-CD19 CAR T-cells
Timeframe: 3 years
3
Maximum concentration (Cmax).
Timeframe: 3 years
4
Time to maximum concentration (Tmax).
Timeframe: 3 years
5
Area-Under-the-Concentration-vs-time curve (AUC) in peripheral blood and/or bone marrow.
Timeframe: 3 years
6
Overall objective response rate (ORR: proportion of patients with confirmed responses of complete [CR] or partial [PR])
. 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.
✕. Donor lymphocyte infusion (DLI) within 4 weeks prior to leukapheresis.
✕. Salvage or debulking chemotherapy within 1 week prior to blood collection for CAR T-cell product manufacture.
✕. Prior central nervous system (CNS) involvement.
✕. Unresolved acute toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 Grade \>1 (or baseline, whichever is greater) from prior anticancer therapy. Alopecia and other nonacute toxicities are acceptable.