Scientists harness Patients' own immune cells to attack Treatment-Resistant melanoma
NCT ID NCT07651618
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2032
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Royal Perth Hospital
Perth, Western Australia, 6000, Australia
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Other studies related to the condition(s) this trial covers.
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