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A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies
Trial Status: active
This study is a Phase 1 dose-escalation and dose-confirmation study to evaluate the
safety and antitumor activity of UB-VV111. The study will enroll patients with
relapsed/refractory large B-cell lymphoma (LBCL) and chronic lymphocytic leukemia (CLL).
Inclusion Criteria
18 years or older
Provides voluntary written informed consent
Relapsed or refractory large B-cell lymphoma (LBCL) or chronic lymphocytic leukemia (CLL)
Measurable disease according to Lugano 2014 criteria (LBCL) or iwCLL 2018 (CLL).
No serious concomitant diseases or active/uncontrolled infections
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ function
Patients who have previously received CD19-directed therapy must have biopsy confirming CD19 expression following completion of prior CD19-directed therapy.
Exclusion Criteria
Women who are pregnant or breastfeeding
Current isolated central nervous system (CNS) involvement
Prior allogeneic bone marrow transplant, gene therapy, or adoptive cell transfer (except CAR T-cell therapy in CAR T-exposed subjects)
History of or active human immunodeficiency virus (HIV)
Active hepatitis B or C
Systemic autoimmune or immunodeficiency diseases, except for well-controlled Type I diabetes or thyroid disease
Ongoing CNS disease that would preclude neurologic assessment
Uncontrolled angina or other acute heart disease
Currently receiving treatment in another interventional clinical trial.
Additional locations may be listed on ClinicalTrials.gov for NCT06528301.
Locations matching your search criteria
United States
California
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available
Florida
Tampa
Moffitt Cancer Center
Status: Active
Name Not Available
Illinois
Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not Available
Missouri
Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available
Nebraska
Omaha
University of Nebraska Medical Center
Status: Active
Name Not Available
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
