Actively Recruiting
A Phase 1, Multicenter, Open-label Study of UB-VV111 in Combination With Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies
Led by Umoja Biopharma · Updated on 2026-05-28
106
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and antitumor activity of UB-VV111, a gene therapy that generates CD19 CAR T cells in the body, for patients with relapsed or refractory large B-cell lymphoma (LBCL) and chronic lymphocytic leukemia (CLL). This Phase 1, open-label study focuses on these CD19+ B-cell malignancies to understand how UB-VV111 works alone and in combination with rapamycin, an FDA-approved drug. Participants will receive either a single dose of UB-VV111 alone or a single dose of UB-VV111 followed by treatment with rapamycin. The study is designed without randomization and includes two experimental arms to compare these approaches. The treatments aim to assess safety and antitumor effects over time. During the study, researchers will monitor participants for common adverse events for up to two years after UB-VV111 administration. They will also evaluate the overall response rate to treatment within this period. Participants will undergo regular assessments to measure disease response and safety, with continuous follow-up to track health outcomes throughout the study duration.
CONDITIONS
Brief 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
- For patients previously treated with CD19-directed therapy, 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 (exceptions include tumor-infiltrating lymphocytes and CAR T cells)
- History of or active human immunodeficiency virus (HIV)
- Active hepatitis B or C
- Systemic 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years after UB-VV111 administration
Participants receive a single dose of UB-VV111, with some also receiving treatment with rapamycin following UB-VV111 administration.
Follow-up visits over 2 years to monitor response and adverse events
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
C
Christine Dehner
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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