Status:
Enrolling
A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies
Phase
I
Age
≥18
Sponsor
Umoja Biopharma
Enrollment code
106
Last Updated
Jul 15, 2025
Locations
8 Countries
Overview
Condition/disease
Large B-Cell Lymphoma, Chronic Lymphocytic Leukemia
Modalities
CAR T Cells, Cell Therapy, Chemotherapy, Immunotherapy, T-cell Therapy
Trial drugs
rapamycin / sirolimus,
UB-VV111
Clinicaltrials.gov ID
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 lymphoma (LBCL) and chronic lymphocytic leukemia (CLL).
Trial locations
Found 8 sites
Washington University School of Medicine/Siteman Cancer Center
USA - MO - Saint Louis
Yalda Karamlou
University of Nebraska Medical Center
USA - NE - Omaha
Brooke Tridle, MHA
St. Vincent's Hospital Melbourne
AU - Fitzroy
Joseph Nguyen-Vo
The David and Etta Jonas Center for Cellular Therapy
USA - IL - Chicago
Michael Bishop, MD
University of Cincinnatti Medical Center
USA - OH - Cincinnatti
Hani Alrefai, MBBCh, MS, PhD
Eligibility criteria
Inclusion criteria:
- 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 criteria:
- 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.
Study plan
Experimental: UB-VV111
A single dose of UB-VV111 will be administered.
Genetic
UB-VV111
UB-VV111 is a gene therapy that generates CD19 CAR T cells in the body.
Experimental: UB-VV111 + rapamycin
A single dose of UB-VV111 will be administered followed by treatment with rapamycin.
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.
Allocation: Non-Randomized
Outcome measures
Primary outcome measures
- Percentage of participants with common adverse events (AEs) (Up to 2 years after UB-VV111 administration)
Secondary outcome measures
- Overall response rate (ORR) (Up to 2 years after UB-VV111 administration)
More information
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
Estimated trial completion date
Mar 1, 2029
Not finding what you’re looking for?
If you’re having trouble using this website or can’t find what you’re looking for, please call us at 1-855-329-5969. Our team is here to help you find your way.
