A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies
Recruiting now · Phase 1
Conditions studied: Lymphoma, B-Cell, Lymphoma, Non-Hodgkin (NHL), Lymphoma, Large B-Cell, Diffuse (DLBCL), Chronic Lymphocytic Leukemia (CLL)
In brief
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).
Key facts
- Study ID
- NCT06528301
- Run by
- Umoja Biopharma
- People needed
- 106
- Starts
- 2025-03-10
- Expected to finish
- 2029-03-01
- Last updated by the study team
- 2026-05-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Women who are pregnant or breastfeeding
- Current isolated central nervous system (CNS) involvement
- Prior allogeneic bone marrow transplant, gene therapy, or adoptive cell transfer (exceptions include tumor-infiltrating lymphocytes and CAR T cells)
- History of or active human immunodeficiency virus (HIV)
- Active hepatitis B or C
- Systemic 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.
Where it is running
- St. Vincent's Hospital Melbourne — Fitzroy, Victoria, Australia (enrolling)
- The David and Etta Jonas Center for Cellular Therapy — Chicago, Illinois, United States (enrolling)
- Washington University School of Medicine/Siteman Cancer Center — St Louis, Missouri, United States (enrolling)
- University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
- University of Cincinnatti Medical Center — Cincinnati, Ohio, United States (enrolling)
- Fred Hutch Cancer Center — Seattle, Washington, United States (enrolling)
- Royal North Shore Hospital — Saint Leonards, New South Wales, Australia (enrolling)
- City of Hope — Duarte, California, United States
Full record on ClinicalTrials.gov
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