A Phase 1a/b Study to Evaluate the Safety and Efficacy of OPB-101, an Autologous Mesothelin (MSLN) CAR T Cell Therapy With Antigen-dependent Expression of OUTSMART™ Designed IL-2 Cytokine in Platinum-resistant Ovarian Cancer
Summary
The goal of this clinical trial is to learn if OPB-101 is safe in platinum resistant ovarian cancer participants and also to find the optimal dose of OPB-101. Participants will have their own T cells modified in a laboratory and given back to them as OPB-101 in this one-time treatment. Participants will be in the hospital when they receive OPB-101 and then be checked at the clinical site frequently for the first few months.
Detailed description
A phase 1a/b study to evaluate the safety and efficacy of OPB-101, an autologous mesothelin (MSLN) CAR T cell therapy with antigen-dependent expression of OUTSMART™ designed IL-2 cytokine in platinum-resistant ovarian cancer.
Arms & interventions
- BiologicalOPB-101
An autologous mesothelin (MSLN) CAR T cell therapy with antigen-dependent expression of OUTSMART designed IL-2 cytokine
Outcome measures
Primary
Safety
Incidence of dose-limiting toxicities (DLTs)
Time frame: 28 days
Safety
Incidence of all treatment-emergent adverse events (TEAEs); Grade 3, 4, 5 TEAEs, serious adverse events (SAEs); deaths due to TEAEs and all deaths
Time frame: 2 years
Safety
To determine the maximum tolerated dose (MTD) of OPB-101 and/or recommended Phase 1b dose(s)
Time frame: 2 years
Eligibility criteria
Study locations (4)
Karmanos Cancer Institute
Detroit, Michigan, 48201
University of Minnesota
Minneapolis, Minnesota, 55455
Roswell Park
Buffalo, New York, 14203
MD Anderson Cancer Center
Houston, Texas, 77030