NCT06528301PHASE1Recruiting
A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies
Umoja Biopharma
Start Date
3/10/2025
Completion Date
3/1/2029
Summary
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).
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
1. 18 years or older
2. Provides voluntary written informed consent
3. Relapsed or refractory large B-cell lymphoma (LBCL) or chronic lymphocytic leukemia (CLL)
4. Measurable disease according to Lugano 2014 criteria (LBCL) or iwCLL 2018 (CLL).
5. No serious concomitant diseases or active/uncontrolled infections
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
7. Adequate organ function
8. Patients who have previously received CD19-directed therapy must have biopsy confirming CD19 expression following completion of prior CD19-directed therapy.
Exclusion Criteria:
1. Women who are pregnant or breastfeeding
2. Current isolated central nervous system (CNS) involvement
3. Prior allogeneic bone marrow transplant, gene therapy, or adoptive cell transfer (exceptions include tumor-infiltrating lymphocytes and CAR T cells)
4. History of or active human immunodeficiency virus (HIV)
5. Active hepatitis B or C
6. Systemic immunodeficiency diseases, except for well-controlled Type I diabetes or thyroid disease
7. Ongoing CNS disease that would preclude neurologic assessment
8. Uncontrolled angina or other acute heart disease
9. Currently receiving treatment in another interventional clinical trial.
Interventions
GENETIC
UB-VV111
DRUG
rapamycin
Conditions
Lymphoma, B-CellLymphoma, Non-Hodgkin (NHL)Lymphoma, Large B-Cell, Diffuse (DLBCL)Chronic Lymphocytic Leukemia (CLL)
Locations
City of Hope
Duarte, California 91010
United States
The David and Etta Jonas Center for Cellular Therapy
Chicago, Illinois 60637
United States
Washington University School of Medicine/Siteman Cancer Center
St Louis, Missouri 63110
United States
University of Nebraska Medical Center
Omaha, Nebraska 68198-6814
United States
University of Cincinnatti Medical Center
Cincinnati, Ohio 45219
United States
Fred Hutch Cancer Center
Seattle, Washington 98109
United States
Royal North Shore Hospital
Saint Leonards, New South Wales 2065
Australia
St. Vincent's Hospital Melbourne
Fitzroy, Victoria 3065
Australia