This is a phase 1, multi-center, single-arm, open-label study evaluating the safety and anti-lymphoma activity of an autologous T cell product (ACTR707) in combination with rituximab in subjects with refractory or relapsed CD20+ B cell lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Yale University
New Haven, Connecticut, United States
Emory University, Winship Cancer Institute
Atlanta, Georgia, United States
Safety as assessed by dose limiting toxicities (DLTs)
Dose-limiting toxicities, MTD, incidence and severity of AEs and clinically significant abnormalities of laboratory values
Time frame: 28 days
Determination of maximum tolerated dose and proposed recommended Phase 2 dose
Time frame: 24 weeks
Anti-lymphoma activity as measured by overall response rate
Time frame: 24 weeks
Anti-lymphoma activity as measured by duration of response
Time frame: 24 weeks
Anti-lymphoma activity as measured by progression-free survival
Time frame: 24 weeks
Anti-lymphoma activity as measure by overall survival
Time frame: 24 weeks
Assessment of persistence of ACTR707 as measured by flow cytometry and qPCR
Time frame: 24 weeks
Assessment of ACTR707 phenotype and function as measured by flow cytometry
Time frame: 24 weeks
Assessment of inflammatory markers and cytokines/chemokines
Cytokines and Inflammatory markers
Time frame: 24 weeks
Rituximab PK
Rituximab plasma concentration
Time frame: 24 weeks
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Loyola University
Maywood, Illinois, United States
Indiana Bone and Marrow Transplantation
Indianapolis, Indiana, United States
University of Maryland
Baltimore, Maryland, United States
University of Minnesota
Minneapolis, Minnesota, United States
Ohio State University
Columbus, Ohio, United States
Tennessee Oncology - Nashville
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
...and 1 more locations