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Engineered immune cells take on tough ovarian cancer in first human trial

NCT ID NCT07030907

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

May 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Female participants only

Healthy volunteers

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

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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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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    4 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Karmanos Cancer Institute

    RECRUITING

    Detroit, Michigan, 48201, United States

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Roswell Park

    RECRUITING

    Buffalo, New York, 14203, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

    Contact Email: •••••@•••••

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