A Study to Evaluate the Safety and Efficacy of OPB-101 in Platinum-resistant Ovarian Cancer
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
Outpace Bio, Inc.
30 participants
Jun 16, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria17
- Age ≥ 18 years of age at the time of signing the informed consent form.
- Histologically confirmed diagnosis of high grade serous epithelial ovarian, peritoneal, or fallopian tube cancer based on local histopathological findings.
- Recurrent platinum-resistant disease defined as: Disease that has recurred within 6 months of the last receipt of platinum-based therapy.
- Received at least 2 prior lines 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 1.
- Adequate organ function.
- Alkaline phosphatase ≤ 2.5 x ULN
- ≤ Grade 1 dyspnea and oxygen saturation levels (SpO2) \> 92% on room air.
- LVEF ≥ 50%
- Life expectancy of ≥ 3 months
- Adequate venous access.
- Negative screen for infectious disease markers.
- Negative serum pregnancy test.
- Abstain from heterosexual activity or to use 2 forms of effective methods of contraception.
Exclusion Criteria21
- 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.
- Active invasive cancer other than the cancer under study.
- Significant lung disease.
- Clinically significant pericardial effusion.
- Prior radiotherapy within 2 weeks of start of study intervention.
- No major surgery within 28 days prior to enrollment.
- Received investigational agents or tumor vaccines.
- Received chemotherapy within the previous 3 weeks.
- History of grade ≥ 3 ascites.
- Active CNS involvement.
- Received a live vaccine within 30 days prior to study treatment.
- Received prior CAR T cell therapy.
- Received prior mesothelin targeted therapy.
Interventions
An autologous mesothelin (MSLN) CAR T cell therapy with antigen-dependent expression of OUTSMART designed IL-2 cytokine
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07030907