Testing UB-VV111 with and without Rapamycin for B-cell cancers
A Phase 1, Multicenter, Open-label Study of UB-VV111 in Combination With Rapamycin in Relapsed/Refractory (R/R) CD19+ B-cell Malignancies
This study is testing a new treatment called UB-VV111, with and without another drug called rapamycin, to see if it can help people with certain types of B-cell cancers that haven't responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Umoja Biopharma Industry-sponsored |
| Drugs / interventions | CAR T |
| Locations | 8 sites (Duarte, California and 7 other locations) |
| Trial ID | NCT06528301 on ClinicalTrials.gov |
What this trial studies
This Phase 1 study evaluates the safety and effectiveness of UB-VV111, both alone and in combination with rapamycin, in patients with relapsed or refractory large B-cell lymphoma and chronic lymphocytic leukemia. The study employs a dose-escalation and dose-confirmation methodology to determine the optimal dosing and assess antitumor activity. Participants must have measurable disease and meet specific eligibility criteria, including adequate organ function and performance status.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with relapsed or refractory large B-cell lymphoma or chronic lymphocytic leukemia.
Not a fit: Patients with isolated central nervous system involvement or those who have had prior allogeneic bone marrow transplants may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat B-cell malignancies.
How similar studies have performed: Other studies involving CAR T-cell therapies have shown promising results, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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 (except CAR T-cell therapy in CAR T-exposed subjects) 4. History of or active human immunodeficiency virus (HIV) 5. Active hepatitis B or C 6. Systemic autoimmune or 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.
Where this trial is running
Duarte, California and 7 other locations
- City of Hope — Duarte, California, United States (Not_yet_recruiting)
- The David and Etta Jonas Center for Cellular Therapy — Chicago, Illinois, United States (Recruiting)
- Washington University School of Medicine/Siteman Cancer Center — St Louis, Missouri, United States (Recruiting)
- University of Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
- University of Cincinnatti Medical Center — Cincinnati, Ohio, United States (Recruiting)
- Fred Hutch Cancer Center — Seattle, Washington, United States (Recruiting)
- Royal North Shore Hospital — Saint Leonards, New South Wales, Australia (Recruiting)
- St. Vincent's Hospital Melbourne — Fitzroy, Victoria, Australia (Recruiting)
Study contacts
- Study coordinator: Jacob Garcia, MD
- Email: jacob.garcia@umoja-biopharma.com
- Phone: 425-873-8331
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.