RECRUITING

A Study to Evaluate the Safety and Efficacy of OPB-101 in Platinum-resistant Ovarian Cancer

Conditions

Ovarian Cancer Recurrent Ovarian Cancer Platinum Resistant Ovarian Cancer Outpace Advanced ovarian cancer cell therapy CAR T

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06-16

Study Completion:2030-05-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07030907

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age ≥ 18 years of age at the time of signing the informed consent form. 2. Histologically confirmed diagnosis of high grade serous epithelial ovarian, peritoneal, or fallopian tube cancer based on local histopathological findings. 3. Recurrent platinum-resistant disease defined as: Disease that has recurred within 6 months of the last receipt of platinum-based therapy. 4. Received at least 2 prior lines of systemic chemotherapy including a platinum-based chemotherapy. 5. Received prior therapy with a PARP inhibitor if the subject has a known germline or somatic BRCA1/2 mutation. 6. Measurable disease. 7. Consent to provide archived tumor tissue sample. 8. ECOG performance status of 0 or 1. 9. Adequate organ function. 10. Alkaline phosphatase ≤ 2.5 x ULN 11. ≤ Grade 1 dyspnea and oxygen saturation levels (SpO2) \> 92% on room air. 12. LVEF ≥ 50% 13. Life expectancy of ≥ 3 months 14. Adequate venous access. 15. Negative screen for infectious disease markers. 16. Negative serum pregnancy test. 17. Abstain from heterosexual activity or to use 2 forms of effective methods of contraception.	1. Women of child-bearing potential who are pregnant or breastfeeding. 2. Uncontrolled bacterial, fungal, or viral infections. 3. Active infection requiring systemic therapy. 4. Bleeding or thrombotic disorders or at risk for severe hemorrhage. 5. Any form of primary immunodeficiency. 6. Had an allogenic tissue/solid organ transplant. 7. Active autoimmune disease. 8. Concurrent treatment with systemic high dose corticosteroids. 9. Unresolved acute effects of any prior therapy. 10. Active invasive cancer other than the cancer under study. 11. Significant lung disease. 12. Clinically significant pericardial effusion. 13. Prior radiotherapy within 2 weeks of start of study intervention. 14. No major surgery within 28 days prior to enrollment. 15. Received investigational agents or tumor vaccines. 16. Received chemotherapy within the previous 3 weeks. 17. History of grade ≥ 3 ascites. 18. Active CNS involvement. 19. Received a live vaccine within 30 days prior to study treatment. 20. Received prior CAR T cell therapy. 21. Received prior mesothelin targeted therapy. 22. Dependent on intravenous hydration or total parenteral nutrition. Note: Other protocol defined exclusion criteria could apply

Inclusion Criteria

Exclusion Criteria

1. Age ≥ 18 years of age at the time of signing the informed consent form.
2. Histologically confirmed diagnosis of high grade serous epithelial ovarian, peritoneal, or fallopian tube cancer based on local histopathological findings.
3. Recurrent platinum-resistant disease defined as: Disease that has recurred within 6 months of the last receipt of platinum-based therapy.
4. Received at least 2 prior lines of systemic chemotherapy including a platinum-based chemotherapy.
5. Received prior therapy with a PARP inhibitor if the subject has a known germline or somatic BRCA1/2 mutation.
6. Measurable disease.
7. Consent to provide archived tumor tissue sample.
8. ECOG performance status of 0 or 1.
9. Adequate organ function.
10. Alkaline phosphatase ≤ 2.5 x ULN
11. ≤ Grade 1 dyspnea and oxygen saturation levels (SpO2) \> 92% on room air.
12. LVEF ≥ 50%
13. Life expectancy of ≥ 3 months
14. Adequate venous access.
15. Negative screen for infectious disease markers.
16. Negative serum pregnancy test.
17. Abstain from heterosexual activity or to use 2 forms of effective methods of contraception.

1. Women of child-bearing potential who are pregnant or breastfeeding.
2. Uncontrolled bacterial, fungal, or viral infections.
3. Active infection requiring systemic therapy.
4. Bleeding or thrombotic disorders or at risk for severe hemorrhage.
5. Any form of primary immunodeficiency.
6. Had an allogenic tissue/solid organ transplant.
7. Active autoimmune disease.
8. Concurrent treatment with systemic high dose corticosteroids.
9. Unresolved acute effects of any prior therapy.
10. Active invasive cancer other than the cancer under study.
11. Significant lung disease.
12. Clinically significant pericardial effusion.
13. Prior radiotherapy within 2 weeks of start of study intervention.
14. No major surgery within 28 days prior to enrollment.
15. Received investigational agents or tumor vaccines.
16. Received chemotherapy within the previous 3 weeks.
17. History of grade ≥ 3 ascites.
18. Active CNS involvement.
19. Received a live vaccine within 30 days prior to study treatment.
20. Received prior CAR T cell therapy.
21. Received prior mesothelin targeted therapy.
22. Dependent on intravenous hydration or total parenteral nutrition. Note: Other protocol defined exclusion criteria could apply

Contacts and Locations

Study Locations (Sites)

University of Minnesota

Minneapolis, Minnesota, 55455

United States

Roswell Park

Buffalo, New York, 14203

United States

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Outpace Bio, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-16

Study Completion Date2030-05-15

Study Record Updates

Study Start Date2025-06-16

Study Completion Date2030-05-15

Terms related to this study

Keywords Provided by Researchers

Outpace
Ovarian cancer
Advanced ovarian cancer
cell therapy
CAR T

Additional Relevant MeSH Terms

Ovarian Cancer Recurrent
Ovarian Cancer
Platinum Resistant Ovarian Cancer