About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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)
Trial design
Sequential
Treatments tested in this trial
UB-VV111
GeneticUB-VV111 is a gene therapy that generates CD19 CAR T cells in the body.
rapamycin
DrugRapamycin is an FDA-approved drug.
Treatment groups
Trial outcomes
Primary outcomes
Percentage of participants with common adverse events (AEs)
Percentage of participants with commonly reported AEs overall and by severity
Secondary outcomes
Overall response rate (ORR)
Percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.