NCT07664735Not yet recruitingPhase 1
A Phase 1a/b Study to Evaluate the Safety and Efficacy of OPB 201, an Autologous PReferentially Expressed Antigen of MElanoma (PRAME) T Cell Receptor (TCR) T Cell Therapy in Recurrent Endometrial and Platinum-resistant Ovarian Cancer.
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Outpace Bio, Inc.
- Enrollment
- 30
Study Overview
Brief Summary
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.
Detailed Description
A phase 1a/b study to evaluate the safety and efficacy of OPB-201, an autologous PReferentially expressed Antigen of MElanoma (PRAME) T cell receptor (TCR) T cell therapy in recurrent endometrial and platinum-resistant ovarian cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •Measurable disease.
- •Consent to provide archived tumor tissue sample.
- •ECOG performance status of 0 or
- •Adequate organ function.
- •HLA-A *02:01 or HLA-A *02:02
- •PRAME positive tumor
Exclusion Criteria
- •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.
- •Any form of primary immunodeficiency.
- •Had an allogenic tissue/solid organ transplant.
- •Active autoimmune disease.
- •Concurrent treatment with systemic high dose corticosteroids.
- •Unresolved acute effects of any prior therapy.
- •Other exclusions as stated in the protocol.
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