Actively Recruiting
A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies
Led by Umoja Biopharma · Updated on 2026-01-12
106
Participants Needed
8
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Previous CD19-directed therapy patients must have biopsy confirming CD19 expression after prior therapy
You will not qualify if you...
- 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 well-controlled Type I diabetes or thyroid disease
- Ongoing CNS disease precluding neurologic assessment
- Uncontrolled angina or other acute heart disease
- Currently receiving treatment in another interventional clinical trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 8 locations
1
City of Hope
Duarte, California, United States, 91010
Not Yet Recruiting
2
The David and Etta Jonas Center for Cellular Therapy
Chicago, Illinois, United States, 60637
Actively Recruiting
3
Washington University School of Medicine/Siteman Cancer Center
St Louis, Missouri, United States, 63110
Actively Recruiting
4
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-6814
Actively Recruiting
5
University of Cincinnatti Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
6
Fred Hutch Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
7
Royal North Shore Hospital
Saint Leonards, New South Wales, Australia, 2065
Actively Recruiting
8
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia, 3065
Actively Recruiting
Research Team
J
Jacob Garcia, MD
CONTACT
C
Christine Dehner
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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