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)
Trial Parameters
Brief 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).
Eligibility Criteria
Inclusion Criteria: 1. Have given written informed consent prior to any study-specific procedures; children (defined as 17 years of age or less) require guardian consent. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; or Karnofsky \> 50%. 3. Age of 2 to 70 years at time of screening. 4. A histologically or cytologically documented, CD19+ non-hodgkin's lymphoma or ALL. 5. 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. 6. Tumor tissue (archival or recent acquisition) must be available for correlative laboratory studies (such as immunohistochemistry, and others). 7. At least 2 prior systemic therapies and patient must not be eligible for potentially curative standard-of-care therapy. 8. Adequate renal function (defined as Cockroft-Gault creatinine clearance \> 50 mL/min) and hepatic function (total bili