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Engineered immune cells take on Hard-to-Treat ovarian and endometrial cancers

NCT ID NCT07664735

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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-phase trial tests a one-time treatment called OPB-201, where a patient's own immune cells are modified in a lab to better recognize and attack cancer cells that carry a protein called PRAME. The study will enroll 30 adults with recurrent endometrial cancer or platinum-resistant ovarian cancer. The main goals are to check if the treatment is safe and to find the best dose.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
OPB-201 (a personalized T cell therapy that targets PRAME, a protein found on cancer cells)
What this could lead to
If successful, this could lead to a new treatment option for people with recurrent endometrial or platinum-resistant ovarian cancer who have few alternatives.
What could go wrong
This is an early Phase 1 trial with only 30 participants, so safety and the right dose are still being figured out. The therapy may not shrink tumors or could cause serious side effects.

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.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Sep 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 endometrial cancer, epithelial ovarian, peritoneal, or fallopian tube cancer based on local histopathological findings. 3. Received at least 1 prior line of systemic chemotherapy including a platinum-based chemotherapy. 4. Received prior therapy with a PARP inhibitor if the subject has a known germline or somatic BRCA1/2 mutation. 5. Measurable disease. 6. Consent to provide archived tumor tissue sample. 7. ECOG performance status of 0 or 1. 8. Adequate organ function. 9. HLA-A \*02:01 or HLA-A \*02:02 10. PRAME positive tumor 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. Other exclusions as stated in the protocol.

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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

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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