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
NCT03277729 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 53
Last updated 2026-01-05
Summary
The purpose of this research is to find the best dose of genetically modified T-cells, to study the safety of this treatment, and to see how well it works in treating patients with B cell non-Hodgkin lymphoma that has come back (relapsed) or did not respond to previous treatment (refractory).
Conditions
- 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
- Recurrent Central Nervous System Lymphoma
- Refractory Central Nervous System Lymphoma
Interventions
- BIOLOGICAL
-
Chimeric Antigen Receptor T-Cell Therapy
Given CD20 CAR T cell IV
- DRUG
-
Given IV
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- PROCEDURE
-
Leukapheresis
Undergo leukapheresis
- DRUG
-
Fludarabine Phosphate
Given IV
Sponsors & Collaborators
-
Mustang Bio
collaborator INDUSTRY -
Fred Hutchinson Cancer Center
lead OTHER
Principal Investigators
-
Mazyar Shadman · Fred Hutch/University of Washington Cancer Consortium
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-12-05
- Primary Completion
- 2024-03-29
- Completion
- 2039-03-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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