RecruitingRecruiting
A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies
NCT06528301 · Umoja Biopharma
In plain English
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Official title
A Phase 1, Multicenter, Open-label Study of UB-VV111 in Combination With Rapamycin in Relapsed/Refractory (R/R) CD19+ B-cell Malignancies
About this study
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
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.
Study design
Enrollment target: 106 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-03-10
Estimated completion: 2029-03
Last updated: 2026-05-28
Interventions
Genetic: UB-VV111Drug: rapamycin
Primary outcomes
- • Percentage of participants with common adverse events (AEs) (Up to 2 years after UB-VV111 administration)
Sponsor
Umoja Biopharma · industry
Contacts & investigators
ContactJacob Garcia, MD · contact · jacob.garcia@umoja-biopharma.com · 425-873-8331
ContactChristine Dehner · contact · christine.dehner@umoja-biopharma.com
InvestigatorJacob Garcia, MD · study_director, Umoja Biopharma
All locations (8)
City of HopeNot Yet Recruiting
Duarte, California, United States
The David and Etta Jonas Center for Cellular TherapyRecruiting
Chicago, Illinois, United States
Washington University School of Medicine/Siteman Cancer CenterRecruiting
St Louis, Missouri, United States
University of Nebraska Medical CenterRecruiting
Omaha, Nebraska, United States
University of Cincinnatti Medical CenterRecruiting
Cincinnati, Ohio, United States
Fred Hutch Cancer CenterRecruiting
Seattle, Washington, United States
Royal North Shore HospitalRecruiting
Saint Leonards, New South Wales, Australia
St. Vincent's Hospital MelbourneRecruiting
Fitzroy, Victoria, Australia