A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell
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).
| Condition(s) | Lymphoma, B-Cell, Lymphoma, Non-Hodgkin (NHL), Lymphoma, Large B-Cell, Diffuse (DLBCL), Chronic Lymphocytic Leukemia (CLL) |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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). |
| Who can participate | 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 transf |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Umoja Biopharma |
| Locations | Duarte, California, United States; Chicago, Illinois, United States; St Louis, Missouri, United States; Omaha, Nebraska, United States; Cincinnati, Ohio, United States; Seattle, Washington, United States (+2 more sites) |
| Start date | 2025-03-10 |
| NCT ID | NCT06528301 |
| Official listing | https://clinicaltrials.gov/study/NCT06528301 |