StudyFinder
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
Status: Recruiting
This study will enroll patients with ovarian cancer who have experienced their cancer worsening after at least two previous treatments. This study will give these patients OPB-101, a genetically engineered CAR-T cell therapy product - a product that will be created from the patient's own T-cells - that the researchers hope has been designed to more accurately recognize and destroy the cancer cells. The goal of this study is to make sure OPB-101 is safe to give, if it is effective against this type of cancer, and to find the best dose of OPB-101 to give patients.
Sex: Female
Age Group: 18 years and over
Inclusion Criteria:
• confirmed diagnosis of high grade serous epithelial ovarian, peritoneal, or fallopian tube cancer
• recurrent platinum-resistant disease, cancer has recurred within 6 months of the last dose of platinum-based chemotherapy
• received at least 2 but no more than 3 prior lines of systemic chemotherapy including a platinum based chemotherapy
• may not be able to do strenuous activity but able to walk and do work of a light or sedentary nature, e.g., light house work, office work
• women childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 12 months after the last dose of therapy
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:
• women who are pregnant or breastfeeding
• uncontrolled bacterial, fungal, or viral infections
• active invasive cancer other than the cancer under study
• significant lung disease
• active central nervous system (CNS) involvement
• dependent on intravenous hydration or total parenteral nutrition
• see link to clinicaltrials.gov for complete exclusion criteria
Interventions:
Biological: OPB-101
Conditions:
Cancer
Keywords:
Clinics and Surgery Center (CSC)
Study Contact: Melissa Geller - gelle005@umn.edu
Principal Investigator: Melissa Geller, MD
Phase: PHASE1
IRB Number: STUDY00025091
See this study on ClinicalTrials.gov