Immune cells from your own tumor could fight lung cancer

NCT ID NCT06473961

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 06, 2026 · Updated 3 times

Summary

This early-stage trial tests a personalized treatment called GC101 TIL for people with advanced non-small cell lung cancer that has not responded to standard treatments. The therapy uses immune cells taken from the patient's own tumor, multiplied in a lab, and then infused back into the patient. The study will enroll 20 participants to check safety and whether the treatment shrinks tumors.

What this could mean

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

Active substance
GC101 TIL (tumor infiltrating lymphocytes)
What this could lead to
If successful, this could point toward a new treatment option for advanced non-small cell lung cancer that has stopped responding to standard therapies.
What could go wrong
This is an early Phase Ib trial with only 20 participants, so results are preliminary. The treatment involves a complex process and may cause side effects; it is not yet proven to work.

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 20 people

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

Started

Oct 2024

Expected to finish

Jul 2028

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 to 70 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\. Signed the informed consent form (ICF) and able to comply with the visits and related procedures specified in the protocol; * 2\. Aged ≥18 years and ≤70 years, regardless of gender; * 3\. Patients with unresectable advanced, recurrent, or metastatic non-small cell lung cancer who are positive for driver genes and have failed after targeted and platinum-containing dual chemotherapy; * 4\. TILs can be isolated from a surgically resectable tumor region: the tissue volume must be \>150mm3, and the lesion has not received local treatment (such as radiotherapy, radiofrequency ablation, oncolytic virus, etc.) or progressed after local treatment; * 5\. There are still at least 1 measurable lesion (according to RECIST1.1 criteria \[see Appendix 4\]) even after TIL sampling and resection of surgically resectable tissue; * 6\. ECOG performance status 0-1; * 7\. Expected survival time \>3 months; * 8\. With sufficient hematology and end-organ function as defined by the following laboratory test results, the test results must be completed and issued within 7 days before tumor tissue collection: * White Blood Cell (WBC)≥2.5×10\^9/L# * Absolute Lymphocyte Count (ANC)≥1.5×10\^9/L; * Absolute Lymphocyte Count(ALC)≥0.7×10\^9/L; * Platelet≥100×10\^9/L# * International Normalized Ratio#INR#≤1.5×ULN; * Activated Partial Thromboplastin Time#APTT#≤1.5×ULN; * Serum Creatinine (Scr)≤1.5mg/dL (or 132.6μmol/L) or Creatinine * Clearance≥60mL/min * Urinalysis: urine protein less than 2+, or 24-hour urine protein \<1g; * Alanine aminotransferase(AST/SGOT) ≤3×ULN; * Alanine aminotransferase (ALT/SGPT) ≤3×ULN; * Total Bilirubin(TBIL)≤1.5×ULN# * 9\. \* Premenopausal women who have not undergone sterilization surgery must agree to use effective contraception measures from the start of study treatment (preconditioning) to one year after cell infusion, and the serum pregnancy test during the screening period must be negative; \*Men who have not undergone sterilization surgery must agree to use effective contraception measures from the start of study treatment (preconditioning) until one year after cell infusion; * 10\. No absolute or relative contraindications for surgery; * 11\. Any melanoma treatment methods, including radiotherapy, chemotherapy, endocrine therapy, targeted therapy, immunotherapy, tumor embolization, or traditional Chinese medicine/herbal medicine treatment with anti-tumor indications, must be stopped 28 days before infusion. If a small molecular targeted drug was used in the previous treatment, the withdrawal time can be shortened to 5 half-lives of the drug used; * 12\. Good compliance and able to adhere to the study visit plan and other agreement requirements. Exclusion Criteria: * 1\. More than 5-line system therapy had been used in previous 3 years before screening period. * 2\. Participation in a clinical trial of another drug or biologic therapy or receipt of a comparable cellular therapy within 28 days prior to infusion; * 3\. Combination of 2 or more malignant tumors, except: Eradicated malignant tumors that have been inactive for ≥5 years prior to study entry and are at minimal risk of recurrence; adequately treated non-melanoma skin cancer or malignant nevus of freckle-like nevus without evidence of disease recurrence; adequately treated carcinoma in situ without evidence of disease recurrence; * 4\. Has received live attenuated vaccination after signing informed consent or is scheduled to receive it during the study; * 5\. Has not recovered from a prior procedure or treatment-related adverse reaction to ≤ grade 1 nci ctcae 5.0 (except for toxicities such as alopecia, etc., which in the judgment of the investigator pose no safety risk); * 6\. Known history of allergy to streptomycin, ciprofloxacin, or micafungin or allergy to any component of the infused product formulation; * 7\. Uncontrolled co-morbidities including, but not limited to, uncontrolled arterial hypertension (systolic blood pressure ≥160 mmhg and/or diastolic blood pressure ≥100 mmhg) even with standardized treatment or any unstable cardiovascular disease including transient ischemic attack, cerebrovascular accident, myocardial infarction, unstable angina pectoris within 6 months prior to enrollment; new york heart association ( nyha class iii or iv congestive heart failure with an ejection fraction \<50%; or severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias, degree ii-iii atrioventricular block, etc., requiring clinical intervention; ecg results showing clinically significant abnormalities or a qtcf ≥450ms (if the first test is abnormal, it may be retested at least 5 minutes apart twice and the combined result/mean value to determine eligibility) ; * 8\. Patients with esophageal or gastric varices that require immediate intervention (e.g., taping or sclerotherapy) or are considered to be at high risk for bleeding based on the opinion of the investigator or consultation with a gastroenterologist or hepatologist, have evidence of portal hypertension (including splenomegaly detected on imaging), or have a prior history of variceal bleeding must have undergone endoscopic evaluation within 3 months prior to enrollment; * 9\. Uncontrolled metabolic disorders, such as diabetes mellitus known to be uncontrolled, or other non-malignant organ or systemic diseases or secondary reactions to cancer, and which can lead to higher medical risk and/or uncertainty in survival evaluation; * 10\. Hepatic encephalopathy, hepatorenal syndrome or child-pugh class b or more severe cirrhosis, liver failure; * 11\. Comorbidity with other serious organic or psychiatric disease; * 12\. Have an active systemic infection requiring treatment with positive blood cultures or imaging evidence of infection, including but not limited to active tuberculosis; * 13\. Be hiv-positive, have a positive serologic test for syphilis, or have clinically active hepatitis a, b, or c, including viral carriers: Hepatitis b, excluding those who are HBsAg-positive; hepatitis c, excluding those who are HCVAb-positive; * 14\. Active autoimmune diseases that still require systemic steroid hormones or other immunosuppressive drugs during the screening period (greater than 10 mg/ day of prednisone or equivalent doses of other hormones); * 15\. Any nci ctcae5.0 immune-related adverse effect (irae) grade ≥ 3 during any prior period of immunotherapy receipt; * 16\. History of organ allograft, allogeneic stem cell transplantation and renal replacement therapy; History of allogeneic t-cell and nk-cell therapy; * 17\. Pulmonary fibrosis, interstitial lung disease (both past history and current), and acute lung disease; Patients with obstructive or restrictive lung disease with FEV1(forced expiratory volume in 1 second) of lung function ≤70%; * 18\. Clinically uncontrollable third space effusions, such as pleural and abdominal effusions that cannot be controlled by drainage or other means prior to enrollment; * 19\. Patients with clinically symptomatic central nervous system metastases (e.g., cerebral edema, need for hormonal intervention, or progression of brain metastases). Patients with prior treatment for brain metastases, such as clinical stability (mri) that has been maintained for at least 2 months and who have discontinued systemic hormone therapy (dose \>10 mg/day prednisone or other equipotent hormone) for \>4 weeks may be included; * 20\. Women who are pregnant or breastfeeding; * 21\. If the investigator believes that other circumstances are not suitable for enrollment.

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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 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

  • Shanghai Chest Hospital

    RECRUITING

    Shanghai, China

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