Status:
RECRUITING
A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies
Lead Sponsor:
Umoja Biopharma
Conditions:
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin (NHL)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 lymp...
Eligibility Criteria
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
- Women who are pregnant or breastfeeding
- Current isolated central nervous system (CNS) involvement
- Prior allogeneic bone marrow transplant, gene therapy, or adoptive cell transfer (except CAR T-cell therapy in CAR T-exposed subjects)
- History of or active human immunodeficiency virus (HIV)
- Active hepatitis B or C
- Systemic autoimmune or 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.
Key Trial Info
Start Date :
March 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT06528301
Start Date
March 10 2025
End Date
March 1 2029
Last Update
July 15 2025
Active Locations (8)
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1
City of Hope
Duarte, California, United States, 91010
2
The David and Etta Jonas Center for Cellular Therapy
Chicago, Illinois, United States, 60637
3
Washington University School of Medicine/Siteman Cancer Center
St Louis, Missouri, United States, 63110
4
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-6814