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Could your own immune cells fight lung cancer? new trial tests safety

NCT ID NCT07498439

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial will test whether infusing a patient's own tumor-fighting immune cells (called TILs) is safe for people with early-stage non-small cell lung cancer that has multiple spots in the lungs. Researchers will collect immune cells from the tumor or lung fluid, grow them in a lab, and give them back to the patient. The main goal is to check for side effects, not yet to see if it works. Fifty adults aged 18 to 75 with confirmed multiple lung nodules will take part.

What this could mean

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

Active substance
Tumor-infiltrating lymphocytes (TILs) - immune cells taken from the patient's own tumor or lung fluid, grown in a lab, and given back as an infusion
What this could lead to
If this treatment is safe, it could point toward a new way to control early-stage lung cancer using the body's own immune cells.
What could go wrong
This is a very early, small safety study, so it is not designed to prove the treatment works. There may be side effects from the infusion, and the approach may not shrink tumors or prevent cancer from coming back.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 50 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Mar 2030

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 75 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. Age 18-75 years, male or female; 2. Imaging findings showing multiple pulmonary nodules persisting after one year of follow-up, clinically diagnosed as multiple lung cancers by two associate senior or higher-level radiologists, two associate senior or higher-level thoracic surgeons, and one associate senior or higher-level oncologist, with patients refusing continued observation; 3. Patients with a history of surgical resection and pathological diagnosis of NSCLC, who subsequently show disease progression on imaging (progression of primary lesion or new nodules) during follow-up or after targeted therapy, diagnosed as lung cancer by a multidisciplinary expert team, and who refuse surgery or other treatments; 4. Ability to obtain a tumor sample of approximately 1-1.5 cm³ via surgery, biopsy, or bronchoscopy for preparation of autologous tumor-infiltrating lymphocytes; 5. ECOG performance status score of 0-2; 6. HGB ≥70 g/L, transfusion-eligible; 7. No severe hepatic, renal, cardiac, or pulmonary dysfunction, meeting the following criteria: Creatinine ≤ 1.5 × ULN; Oxygen saturation \> 90%; Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; 8. Estimated survival \> 5 years with complete clinical documentation. Exclusion Criteria: 1. Patients with pathological diagnosis of small cell lung cancer components; 2. Suspicious lesions appearing and follow-up duration less than six months, or remission after anti-inflammatory treatment; 3. Previous history of allogeneic organ transplantation or cytoreductive therapy including lymph node clearance; 4. Patients currently undergoing steroid therapy; 5. Concurrent severe or persistent infections unresponsive to effective control; 6. Concurrent severe autoimmune disease or congenital immunodeficiency; 7. History of severe allergic reactions to biological products (including antibiotics); 8. Active hepatitis (quantitative hepatitis B virus DNA \[HBV-DNA\] above the lower limit of detection for the assay method, or positive hepatitis C antibodies \[HCV-Ab\] with HCV-RNA above the assay method's lower limit of detection); 9. HIV infection or syphilis infection; 10. Female patients who are pregnant, breastfeeding, or planning pregnancy within 12 months; 11. Conditions deemed by the investigator to potentially increase subject risk or interfere with trial results.

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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 official record

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

    Open the record ↗

  2. 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.