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
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03277729|
Recruitment Status : Recruiting
First Posted : September 11, 2017
Last Update Posted : July 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Recurrent B-Cell Non-Hodgkin Lymphoma Recurrent Chronic Lymphocytic Leukemia Recurrent Diffuse Large B-Cell Lymphoma Recurrent Follicular Lymphoma Recurrent Lymphoplasmacytic Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Marginal Zone Lymphoma Refractory B-Cell Non-Hodgkin Lymphoma Refractory Diffuse Large B-Cell Lymphoma Refractory Follicular Lymphoma Refractory Lymphoplasmacytic Lymphoma Refractory Mantle Cell Lymphoma Refractory Transformed Non-Hodgkin Lymphoma Recurrent Transformed B-Cell Non-Hodgkin Lymphoma Recurrent Transformed Chronic Lymphocytic Leukemia Refractory Marginal Zone Lymphoma Refractory Transformed B-Cell Non-Hodgkin Lymphoma Refractory Transformed Chronic Lymphocytic Leukemia Recurrent Small Lymphocytic Lymphoma Refractory Chronic Lymphocytic Leukemia Refractory Small Lymphocytic Lymphoma||Biological: Chimeric Antigen Receptor T-Cell Therapy Drug: Cyclophosphamide Other: Laboratory Biomarker Analysis Procedure: Leukapheresis Drug: Fludarabine Phosphate||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||December 5, 2017|
|Estimated Primary Completion Date :||November 16, 2022|
|Estimated Study Completion Date :||November 16, 2037|
Experimental: Treatment (CD20-specific CAR T cell, chemotherapy)
Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes.
Biological: Chimeric Antigen Receptor T-Cell Therapy
Given CD20 CAR T cell IV
Other: Laboratory Biomarker Analysis
Drug: Fludarabine Phosphate
- Dose-limiting toxicity [ Time Frame: Up to 28 days ]Will be graded by Common Terminology Criteria for Adverse Events version 4.0.
- Complete remission [ Time Frame: Up to 15 years ]Will be assessed based on the Lugano criteria.
- Progression-free survival (PFS) [ Time Frame: Duration from study enrollment to progression or death due to any cause (whichever comes first), assessed up to 15 years ]A Cox proportional hazards model will be used to evaluate PFS.
- Overall survival (OS) [ Time Frame: Duration from study enrollment to death due to any cause, assessed up to 15 years ]A Cox proportional hazards model will be used to evaluate OS.
- Incidence of adverse events [ Time Frame: Up to 15 years ]Will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03277729
|Contact: SCCA Immunotherapy Intakefirstname.lastname@example.org|
|Contact: SCCA Immunotherapy Intake||855-557-0555|
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: SCCA Immunotherapy Intake 206-606-4668 email@example.com|
|Contact: SCCA Immunotherapy Intake 855-557-0555|
|Principal Investigator: Mazyar Shadman|
|Principal Investigator:||Mazyar Shadman||Fred Hutch/University of Washington Cancer Consortium|