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Could your own tumor cells beat melanoma? new trial tests immune cell therapy

NCT ID NCT05098184

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This early-phase trial tests a therapy made from a patient's own tumor-fighting immune cells (TILs) for advanced melanoma. Doctors take TILs from a tumor sample, grow them in the lab, and infuse them back after a short chemotherapy course. The study aims to see if this approach is safe and can shrink tumors in 50 people who have not responded to standard treatments.

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)
What this could lead to
If successful, this could offer a new treatment option for advanced melanoma patients who have run out of standard therapies.
What could go wrong
This is a very early, small trial (50 people) focused on safety. The treatment may not shrink tumors, and side effects from the lymphodepletion regimen can be serious.

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.

Started

Sep 2021

Expected to finish

Sep 2026

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 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 years to 75 years; 2. Histologically diagnosed as primary/relapsed/metastasized melanoma; 3. Expected life-span more than 3 months; 4. Karnofsky≥60% or ECOG score 0-2; 5. Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available. 6. Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated; 7. At least 1 evaluable tumor lesion; 8. Hematology and Chemistry(within 7 days prior to enrollment): * Absolute count of white blood cells≥2.5×10\^9/L; * Absolute count of neutropils≥1.5×10\^9/L; * Absolute count of lymphocytes ≥0.7×109/L; * Platelet count≥100×10\^9; * hemoglobin≥90 g/L; * Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days); * International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days); * Serum creatinine ≤1.5mg/dL(or ≤132.6μmol/L), or clearance rate≥50mL/min; * Serum ALT/AST ≤3×ULN(subjects with liver metastasis ≤3×ULN); * Totol bilirubin≤1.5×ULN; 9. no absolute or relative contraindications to operation or biopsy; 10. Test subjects with child-bearing potential must be willing to practice approved highly effective methods of contraception at the time of informed consent, and continue within 1 year after the completion of lymphodepletion; 11. Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy and biologics must cease 28 days before obtaining TILs; 12. Be able to understand and sign the informed consent document; 13. Be able to stick to follow-up visit plan and other requirements in the agreement. Exclusion Criteria: 1. Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment; 2. Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%; 3. Significant cardiovascular anomalies according to any of the following definition: New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrio-ventricular conductive block, etc. 4. Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and/or anti-HCV positive), syphilis infection or Treponema pallidum antibody positive; 5. Severe physical or mental diseases; 6. Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection); 7. Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy; 8. History of allergy to chemical compound consisting of chemical and biologic substances resembling cell therapy; 9. Having received immunotherapy and developed irAE level greater than Level 3; 10. Previous anti-tumor treatment AE did not return to CTCAE5.0 version grade 1 or below (toxicity considered by the investigator as non-safety concerns like alopecia excluded); 11. Females in pregnancy or lactation; 12. History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy; 13. Researchers considering the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.

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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 Tenth People's Hospital

    RECRUITING

    Shanghai, China

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