Engineered immune cells take on tough ovarian cancer in first human trial
NCT ID NCT07030907
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial is testing a one-time treatment called OPB-101 for women with ovarian cancer that no longer responds to platinum chemotherapy. The therapy uses a patient's own immune cells (T cells) that are modified in a lab to better recognize and attack cancer cells, plus a built-in boost to help them work longer. The main goals are to check safety and find the right dose in 30 participants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- OPB-101 (a CAR T cell therapy made from the patient's own immune cells, engineered to target mesothelin and produce IL-2)
- What this could lead to
- If successful, this could point toward a new treatment option for women with hard-to-treat ovarian cancer that has stopped responding to standard chemotherapy.
- What could go wrong
- This is a very early (Phase 1) and small (30 people) trial focused mainly on safety. The therapy may not shrink tumors or may cause serious side effects. It is not a cure and requires ongoing monitoring.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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May 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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. Note: Other protocol defined inclusion criteria could apply Exclusion Criteria: 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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Karmanos Cancer Institute
RECRUITINGDetroit, Michigan, 48201, United States
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MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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Roswell Park
RECRUITINGBuffalo, New York, 14203, United States
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University of Minnesota
RECRUITINGMinneapolis, Minnesota, 55455, United States
Contact Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Patient's own immune cells fight ovarian cancer?
- Ovarian Cancer's spread: scientists probe abdominal fluid for clues
- New PET tracer aims to light up hidden cancer targets
- Can inhaled manganese make ovarian cancer immunotherapy hit harder?
- Can a pill shrink Hard-to-Treat ovarian tumors?
- New antibody aims to preserve immune checkpoint while fighting cancer