Phase I/II Study of Immunotherapy for Advanced CD19+ Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma With Defined Subsets of Autologous T Cells Engineered to Express a CD19-specific Chimeric Antigen Receptor.
I. To evaluate the feasibility and safety of adoptive T cell therapy using ex vivo expanded
autologous CD8+ and CD4+ CD19 chimeric antigen receptor (CAR)-T cells for patients with
advanced CD19+ B cell malignancies.
I. To determine the duration of in vivo persistence of adoptively transferred T cells, and
the phenotype of persisting T cells.
II. To determine if adoptively transferred T cells traffic to the bone marrow and function
III. To determine if the adoptive transfer of CD19 CAR-T cells results in depletion of CD19+
B cells in vivo as a surrogate for functional activity.
IV. To determine if the adoptive transfer of CD19 CAR-T cells has antitumor activity in
patients with measurable tumor burden prior to T cell transfer.
V. To determine if the adoptive transfer of CD19 CAR-T cells is associated with tumor lysis
OUTLINE: This is a dose-escalation study of autologous CD19 CAR T-cells.
Patients receive anti-CD19-CAR lentiviral vector-transduced autologous T cells intravenously
(IV) over 20-30 minutes on day 0. Treatment may be repeated in 30 days if there is
persistent disease in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed up for 15 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Highest dose of T cells that is estimated to result in grade 3 or greater toxicity, using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, in less than or equal to 1/3 patients and antitumor activity.
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
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