A PHASE 1, MULTICENTER, OPEN-LABEL STUDY OF UB-VV111 IN COMBINATION WITH RAPAMYCIN IN RELAPSED OR REFRACTORY (R/R) CD19+ B-CELL MALIGNANCIES
Categories (click each to see list of all clinical trials associated with that category): Cellular Therapy Support Service - CAR-T (ONC), Lymphoma/CLL (ONC)
Current Status: Open
Phase: I (Cancer Control)
Principal Investigator: Lunning, Matthew
Contact Information:
Brooke Tridle
brtridle@unmc.edu
Summary
Primary:
1. To determine the safety profile of UB-VV111 +/- rapamycin in adult subjects with R/R Large B Cell Lymphomas and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
2. To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and recommended Phase 2 dose (RP2D) of UB-VV111 +/- rapamycin in CAR-naïve and CAR-exposed subjects.
Secondary: To assess preliminary antitumor activity of UB-VV111 +/-rapamycin
Exploratory:
1. To assess depth and durability of antitumor activity of UB-VV111 +/- rapamycin
2. To explore biomarkers of response and toxicity to UB-VV111 +/- rapamycin.
3. To assess the pharmacokinetics (PK) and pharmacodynamics (Pd) of UB-VV111 (± rapamycin)
4. To explore the immunogenicity of UB-VV111 and associated payload components
5. To assess vector copy number (VCN) impact on safety, efficacy, and PK/Pd attributes of UB-VV111 ± rapamycin.
6. To assess in tumor biopsies the impact of the tumor microenvironment (TME) on UB VV111 PK, Pd, and anti-tumor activity
7. To assess the impact of biomarkers on safety/preliminary anti-tumor activity