Trials / Recruiting
RecruitingNCT06528301
A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies
A Phase 1, Multicenter, Open-label Study of UB-VV111 in Combination With Rapamycin in Relapsed/Refractory (R/R) CD19+ B-cell Malignancies
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 106 (estimated)
- Sponsor
- Umoja Biopharma · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
- Lymphoma, B-Cell
- Lymphoma, Non-Hodgkin (NHL)
- Lymphoma, Large B-Cell, Diffuse (DLBCL)
- Chronic Lymphocytic Leukemia (CLL)
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | UB-VV111 | UB-VV111 is a gene therapy that generates CD19 CAR T cells in the body. |
| DRUG | rapamycin | Rapamycin is an FDA-approved drug. |
Timeline
- Start date
- 2025-03-10
- Primary completion
- 2029-03-01
- Completion
- 2029-03-01
- First posted
- 2024-07-30
- Last updated
- 2026-01-12
Locations
8 sites across 2 countries: United States, Australia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06528301. Inclusion in this directory is not an endorsement.