Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
54

Summary

Conditions
  • Recurrent Chronic Lymphocytic Leukemia
  • CD19-Positive Neoplastic Cells Present
  • Refractory Non Hodgkin Lymphoma
  • Recurrent Adult Acute Lymphoblastic Leukemia
  • Recurrent Diffuse Large B-Cell Lymphoma
  • Refractory Small Lymphocytic Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Non-Hodgkin Lymphoma
  • Recurrent Small Lymphocytic Lymphoma
  • Refractory Acute Lymphoblastic Leukemia
  • Refractory Chronic Lymphocytic Leukemia
  • Refractory Diffuse Large B Cell Lymphoma
  • Refractory Mantle Cell Lymphoma
Type
Interventional
Phase
Phase 1Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

PRIMARY OBJECTIVES: I. To evaluate the feasibility and safety of adoptive T cell therapy using ex vivo expanded autologous CD8 positive (+) and CD4+ CD19 chimeric antigen receptor (CAR)-T cells for patients with advanced CD19+ B cell malignancies. SECONDARY OBJECTIVES: I. To determine the duration o...

PRIMARY OBJECTIVES: I. To evaluate the feasibility and safety of adoptive T cell therapy using ex vivo expanded autologous CD8 positive (+) and CD4+ CD19 chimeric antigen receptor (CAR)-T cells for patients with advanced CD19+ B cell malignancies. SECONDARY OBJECTIVES: 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 in vivo. 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 syndrome. OUTLINE: This is a phase I, dose-escalation study of autologous CD19 CAR T-cells followed by a phase II study. 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 no less than 21 days with or without additional lymphodepleting chemotherapy if there is persistent disease in the absence of unacceptable toxicity. DOSE DENSE EXPANSION COHORT: An additional cohort will receive a second anti-CD19-CAR lentiviral vector-transduced autologous T cell infusion without additional lymphodepleting chemotherapy 10-21 days after the first infusion if adequate CD19 CAR-T cells can be produced and appropriate criteria are met. After completion of study treatment, patients are followed up for at least 15 years.

Tracking Information

NCT #
NCT01865617
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: David Maloney Fred Hutch/University of Washington Cancer Consortium