A Phase 1, Multicenter, Open-label Study of UB-VV111 in Combination With Rapamycin in Relapsed/Refractory (R/R) CD19+ B-cell Malignancies
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).
Arms & 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.
Outcome measures
Primary
Percentage of participants with common adverse events (AEs)
Percentage of participants with commonly reported AEs overall and by severity
Time frame: Up to 2 years after UB-VV111 administration
Secondary
Overall response rate (ORR)
Time frame: Up to 2 years after UB-VV111 administration
Eligibility criteria
Study locations (6)
City of Hope
Duarte, California, 91010
The David and Etta Jonas Center for Cellular Therapy
Chicago, Illinois, 60637
Washington University School of Medicine/Siteman Cancer Center
St Louis, Missouri, 63110
University of Nebraska Medical Center
Omaha, Nebraska, 68198-6814
University of Cincinnatti Medical Center
Cincinnati, Ohio, 45219
Fred Hutch Cancer Center
Seattle, Washington, 98109