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Could your own immune cells fight brain tumors? new trial tests lifileucel

NCT ID NCT05640193

Disease control Sponsor: Memorial Sloan Kettering Cancer Center Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

This early-phase trial is testing a personalized cell therapy called lifileucel in 10 people with melanoma that has spread to the brain and is no longer responding to standard immunotherapy. Doctors remove a piece of the tumor, grow the patient's own immune cells in the lab, and then infuse them back after a short course of chemotherapy. The main goal is to see if this approach is feasible and safe in this specific group of patients.

What this could mean

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

Active substance
Lifileucel (a personalized cell therapy made from the patient's own tumor-fighting immune cells)
What this could lead to
If it works, this could offer a new treatment option for melanoma that has spread to the brain and stopped responding to standard immunotherapy.
What could go wrong
This is a very early, small pilot trial with only 10 participants, so results may not apply broadly. The therapy involves surgery and strong chemotherapy, which carry serious risks.

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

10 people

The number who actually took part.

Started

Nov 2022

Expected to finish

Nov 2027

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 years and older

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. Metastatic melanoma with asymptomatic brain metastases 2. At least one resectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post-resection to generate TIL 3. Must be ≥ 18 years of age at time of consent 4. ECOG performance status of 0-1 and estimated life expectancy of ≥ 3 months 5. Adequate hematologic parameters and organ function Exclusion Criteria: 1. Received organ allograft, except kidney transplant, or prior cell transfer therapy including TIL and CAR-T therapies 2. Ongoing grade 2-4 toxicity from prior immunotherapy (excluding endocrine, ocular toxicity or vitiligo) 3. History of hypersensitivity to any component or excipient of lifileucel or other treatment regimen drugs 4. Symptomatic brain metastases 5. Chronic systemic steroid therapy of \> 10 mg/day 6. Active medical illness(es) that would pose increased risk for protocol participation 7. Must have negative syphilis assay and be seronegative for HIV, positive serology for HBV must have corresponding PCR assay and may be enrolled if viral load by PCR is undetectable 8. Primary immunodeficiency 9. Received live or attenuated vaccine within 28 days prior to beginning NMA-LD 10. Pregnant or breastfeeding 11. Patients who cannot receive gadolinium-enhanced MRI.

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Conditions

The condition(s) this trial relates to.

melanoma metastatic melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic melanoma

Contacts and locations

Locations

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065, United States

More trials for these conditions

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