A Phase 1, Multicenter, Open-label Study of UB-VV111 in Combination With Rapamycin in Relapsed/Refractory (R/R) CD19+ B-cell Malignancies
Umoja Biopharma
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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. Exc…
Interventions
- GeneticUB-VV111
UB-VV111 is a gene therapy that generates CD19 CAR T cells in the body.
- Drugrapamycin
Rapamycin is an FDA-approved drug.
Locations (8)
- City of HopeDuarte, California
- The David and Etta Jonas Center for Cellular TherapyChicago, Illinois
- Washington University School of Medicine/Siteman Cancer CenterSt Louis, Missouri
- University of Nebraska Medical CenterOmaha, Nebraska
- University of Cincinnatti Medical CenterCincinnati, Ohio
- Fred Hutch Cancer CenterSeattle, Washington