A Phase I/II Study to Evaluate the Safety of Cellular Immunotherapy Using Autologous T Cells Engineered to Express a CD20-Specific Chimeric Antigen Receptor for Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphomas
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 30
Summary
- Conditions
- Recurrent B-Cell Non-Hodgkin Lymphoma
- Recurrent Chronic Lymphocytic Leukemia
- Recurrent Diffuse Large B-Cell Lymphoma
- Recurrent Follicular Lymphoma
- Refractory Transformed B-Cell Non-Hodgkin Lymphoma
- Recurrent Lymphoplasmacytic Lymphoma
- Refractory Transformed Non-Hodgkin Lymphoma
- Refractory Lymphoplasmacytic Lymphoma
- Refractory Diffuse Large B Cell Lymphoma
- Refractory Follicular Lymphoma
- Refractory Transformed Chronic Lymphocytic Leukemia
- Recurrent Mantle Cell Lymphoma
- Refractory Chronic Lymphocytic Leukemia
- Recurrent Marginal Zone Lymphoma
- Recurrent Small Lymphocytic Lymphoma
- Recurrent Transformed B-Cell Non-Hodgkin Lymphoma
- Recurrent Transformed Chronic Lymphocytic Leukemia
- Refractory Mantle Cell Lymphoma
- Refractory B-Cell Non-Hodgkin Lymphoma
- Refractory Marginal Zone Lymphoma
- Refractory Small Lymphocytic 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
OUTLINE: This is a phase I/II dose-escalation study of CD20-specific CAR T cell therapy. Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide intravenously (IV). Patients may also receive fludarabine IV. After 36-96 hour...
OUTLINE: This is a phase I/II dose-escalation study of CD20-specific CAR T cell therapy. Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide intravenously (IV). Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes. Patients will be actively participating in the study for approximately 15 months. The total time includes the time for the T cells to be made, the T cell infusion, and for approximately 12 months after the T cell infusion is given. After completion of study treatment, patients are followed up for a minimum of 15 years.
Tracking Information
- NCT #
- NCT03277729
- Collaborators
- National Cancer Institute (NCI)
- Mustang Bio
- Investigators
- Principal Investigator: Mazyar Shadman Fred Hutch/University of Washington Cancer Consortium
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