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Personalized cell therapy takes on Lung-Lining tumors

NCT ID NCT07192900

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 05, 2026 · Updated 3 times

Summary

This early-phase trial is testing a new immunotherapy called Fast TILs for people with metastatic cancer or mesothelioma that has spread to the pleura (the lining around the lungs). The treatment uses the patient's own immune cells collected from their pleural fluid, which are multiplied in a lab and then delivered back into the chest through a catheter, along with a low dose of Interleukin-2. The main goals are to see if this approach is safe and if the personalized cell product can be made reliably. Only 10 participants will be enrolled, and the active treatment lasts about three weeks, with follow-up over five years.

What this could mean

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

Active substance
Fast TILs (immune cells from the patient's own pleural fluid) plus Interleukin-2
What this could lead to
If it works, this could point toward a new treatment option for people with cancer that has spread to the lining of the lungs.
What could go wrong
This is a very early, first-in-human trial with only 10 participants. The treatment may not work, and there are unknown risks, including 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 10 people

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

Started

Jun 2026

Expected to finish

Apr 2038

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 79 years

Sex

Anyone

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. Patients with symptomatic, biopsy-proven malignant to the pleura, or mesothelioma with pleural effusions. Patients must have received and be refractory to available standard of care (SOC) therapy specific to their cancer type and must have exhausted or failed available standard of care with clinical benefit. 2. Patients will be ≥ 18 and \< 80 years of age. 3. Female patients of childbearing potential must have a negative urine or serum pregnancy test and if sexually active must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), an injectable contraceptive (such as Depo-Provera), or an oral contraceptive. Active contraception should continue for at least 12 months after ACT administration. Male participants must be willing to practice birth control from the time of enrollment on this study and for 4 months after receiving the preparative regimen. 4. Cardiac ejection fraction ≥ 0.45 by Multiple-Gated Acquisition (MUGA) or echocardiography. 5. No requirement for supplemental oxygen and no dyspnea immediately after effusion drainage. 6. ECOG Performance Status 0 or 1. 7. Patients must have an expected survival \> 12 weeks. 8. Patients must be able to comprehend the risks and methods used in this clinical trial and independently consent to participate. 9. Patients must consent to collection of demographic and clinical data. Exclusion Criteria: 1. Patients with breast, kidney, lung, pancreatic, prostate, ovarian, rare cancers, and melanoma. 2. Infection with Human Immunodeficiency Virus (HIV) and active viral replication. Patients with an undetectable viral load on Anti-retroviral Therapy (ART) can be considered for participation on this protocol. 3. Infection with hepatitis B and active viral replication. 4. Infection with hepatitis C and active viral replication. 5. Patients currently being treated for bacterial, fungal or viral infection. 6. Documented myocardial infarction within 6 months of study participation and/or symptomatic coronary artery or valvular disease or uncontrolled arrhythmia. 7. Investigational drug use within 30 days before effusion collection. 8. Cytotoxic anti-cancer or radiation therapy administration within 2 weeks of effusion collection. The exclusion does not apply to patients receiving monoclonal antibody therapy targeting immune checkpoint molecules. 9. Corticosteroid therapy \> 10 milligrams (mg) of prednisone (biological equivalent) daily within 2 weeks before effusion collection. 10. Immunosuppressive therapy that cannot be stopped for 4 weeks prior to effusion collection as deemed by the prescribing physician. 11. Laboratory abnormalities that indicate clinically significant hematological, hepatobiliary, or renal disease: AST/SGOT \> 2.0 times the upper limit of normal ALT/SGPT \> 2.0 times the upper limit of normal Total bilirubin \> 2.0 times the upper limit of normal, unless patient has Gilbert Syndrome (\>3.0 times the upper limit of normal) Hemoglobin \< 8 gm/dL or dependent upon transfusion to maintain ≥ 8 gm/dL White blood cell count \< 2,000/mm3 Platelet count \< 100,000/mm3 or dependent upon transfusion to maintain ≥ 100,000 mm3 Creatinine \> 2.0 times the upper limit of normal or calculated creatinine clearance ≤ 40 mL/min. 12. Pregnant or lactating females. 13. Prior solid organ transplantation 14. Patients who, in the opinion of the Investigator, will be non-compliant with study schedules or procedures. 15. Patients who belong to a vulnerable population such as the homeless, the developmentally disabled and prisoners or have any condition that impairs their ability to provide informed consent or comply with study schedules or procedures. 16. Patients with documented anaphylaxis as a result of penicillin allergy.

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Conditions

The condition(s) this trial relates to.

malignant mesothelioma Mesothelioma, Malignant Pleural Effusion, Malignant

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 places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • AHN West Penn Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

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