The goal of this clinical trial is to learn if OPB-201 is safe in recurrent endometrial and platinum resistant ovarian cancer participants and also to find the optimal dose of OPB-201. Participants will have their own T cells modified in a laboratory and given back to them as OPB-201 in this one-time treatment. Participants will be in the hospital when they receive OPB-201 and then be checked at the clinical site frequently for the first few months.
Age ≥ 18 years of age at the time of signing the informed consent form.
Histologically confirmed diagnosis of endometrial cancer, epithelial ovarian, peritoneal, or fallopian tube cancer based on local histopathological findings.
Received at least 1 prior line of systemic chemotherapy including a platinum-based chemotherapy.
Received prior therapy with a PARP inhibitor if the subject has a known germline or somatic BRCA1/2 mutation.
Women of child-bearing potential who are pregnant or breastfeeding.
Uncontrolled bacterial, fungal, or viral infections.
Active infection requiring systemic therapy.
Bleeding or thrombotic disorders or at risk for severe hemorrhage.
Single group
OPB-201
Biological/VaccineA multi-transgene autologous TCR T cell therapy with optimized alpha and beta chains of a TCR specific for a peptide derived from PRAME and a designed protein which enhances TCR T cell potency.
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.
Safety
Incidence of dose-limiting-toxicities (DLTs)
Safety
To determine the maximum tolerated dose (MTD) of OPB-201 and/or recommended Phase 1b dose(s)
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This trial is not recruiting at the moment. You can still explore other options:
