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Scientists harness Patients' own immune cells to attack Treatment-Resistant melanoma

NCT ID NCT07651618

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a therapy called Perkileucel, made from a patient's own immune cells (tumor-infiltrating lymphocytes). These cells are collected from a surgically removed melanoma tumor, grown in a lab, and then infused back into the patient. Before the infusion, patients receive a short course of chemotherapy to prepare their body. The goal is to see if this personalized cell therapy can shrink or control melanoma that has not responded to immune checkpoint inhibitors. The trial involves 10 adults with advanced melanoma and includes close monitoring for safety and effectiveness over several years.

What this could mean

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

Active substance
Perkileucel (tumor-infiltrating lymphocytes)
What this could lead to
If it works, this could offer a new treatment option for people with advanced melanoma that has stopped responding to other therapies.
What could go wrong
This is a small, early-phase trial, so results may not apply to everyone. The treatment involves intensive chemotherapy and carries risks like infection and organ damage.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 10 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Apr 2032

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

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. Adult patients = 18 years = 70 years of age. 2. ECOG 0-1 (Appendix A: Eastern Cooperative Oncology Group Performance Status Scale) with an estimated life expectancy of \> 6 months 3. Histologically confirmed unresectable or stage IV melanoma as per AJCC 8th edition. Unresectable melanoma is defined where the lesions are deemed to be unresectable by the treating surgeon. 4. Metastatic melanoma with at least 1 surgically accessible metastatic lesion (or aggregate lesions) with an estimated minimum diameter of = 1.5 cm 5. Measurable disease per RECIST 1.1 criteria (in addition to the resected lesion). 6. At least one anti-PD1 containing line of systemic therapy for unresectable or metastatic melanoma. Alternatively, one prior line of an adjuvant or neoadjuvant anti-PD1 containing regimen and all related adverse events have either returned to baseline or stabilized. Exclusion Criteria: 1. Life expectancy of less than 3 months. 2. Metastatic uveal melanoma. 3. Requirement for immunosuppressive doses of systemic corticosteroids (\>10 mg/day prednisone or equivalent) or other immunosuppressive drugs (e.g. mycophenolate, infliximab, or others) within the last 3 weeks prior to patient screening. Participants receiving steroids as replacement therapy for adrenocortical insufficiency at =10 mg/day of prednisone or another steroid equivalent dose are acceptable. 4. Participant has symptomatic untreated brain metastases. * A participant with historically treated brain metastases (ie, treatment was completed \>60 days prior to consenting for study participation) may be considered for study participation if the participant is clinically and radiologically stable for = 60 days * Participants with previously known asymptomatic brain metastases who do not clinically require treatment may be enrolled. 5. More than three melanoma brain metastases or evidence of leptomeningeal disease Other protocol defined exclusion criteria could apply.

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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

  • Royal Perth Hospital

    Perth, Western Australia, 6000, Australia

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Other studies related to the condition(s) this trial covers.