Tests UB-VV111 with or without rapamycin in relapsed B-cell lymphoma or leukemia
Tests UB-VV111, with or without rapamycin, in adults with returning B-cell lymphoma or leukemia.
Plain-language title generated from the registry record
Registry title: A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies
Key facts
- Where
- Fitzroy and Saint Leonards, AustraliaSee the 2 sites
- Phase
- Phase 1
Where in Australia
- St Vincent's Hospital MelbourneFitzroy, AustraliaTaking people
- Royal North Shore HospitalSaint Leonards, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Umoja Biopharma
- Trial code
- NCT06528301
- Record updated
- 15 October 2026
- Original description
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).Read full original descriptionShow less
A Phase 1, Multicenter, Open-label Study of UB-VV111 in Combination With Rapamycin in Relapsed/Refractory (R/R) CD19+ B-cell Malignancies
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: 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: Currently receiving treatment in another interventional clinical trial; 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; Prior allogeneic bone marrow transplant, gene therapy, or adoptive cell transfer (exceptions include tumor-infiltrating lymphocytes and CAR T cells); Women who are pregnant or breastfeeding; Current isolated central nervous system (CNS) involvement.