Metastatic MelanomaPhase 1NCT05640193
A Study of LN-144 in People With Metastatic Melanoma to the Brain
A Phase 1 study testing Lifileucel (LN-144) in people with Metastatic Melanoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
This is an open label study evaluating lifileucel (LN-144) in patients with melanoma brain metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- Lifileucel (LN-144)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2022to Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metastatic melanoma with asymptomatic brain metastases
- At least one resectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post-resection to generate TIL
- Must be ≥ 18 years of age at time of consent
- ECOG performance status of 0-1 and estimated life expectancy of ≥ 3 months
- Adequate hematologic parameters and organ function
Who cannot join
- Received organ allograft, except kidney transplant, or prior cell transfer therapy including TIL and CAR-T therapies
- Ongoing grade 2-4 toxicity from prior immunotherapy (excluding endocrine, ocular toxicity or vitiligo)
- History of hypersensitivity to any component or excipient of lifileucel or other treatment regimen drugs
- Symptomatic brain metastases
- Chronic systemic steroid therapy of > 10 mg/day
- Active medical illness(es) that would pose increased risk for protocol participation
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- 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
- Primary immunodeficiency
- Received live or attenuated vaccine within 28 days prior to beginning NMA-LD
- Pregnant or breastfeeding
- Patients who cannot receive gadolinium-enhanced MRI.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
About this study
Official title: Pilot Trial of Lifileucel (LN-144) for Patients With Asymptomatic Melanoma Brain Metastases and Progression on Prior PD1 Therapy
This is an open label study evaluating lifileucel (LN-144) in patients with melanoma brain metastases.
Read the detailed description
Lifileucel (LN-144) is an autologous Tumor Infiltrating Lymphocytes (TIL) cell therapy that utilizes a 22-day centralized GMP process. Lifileucel is infused as part of a treatment regimen that includes preparative NMA-LD, followed by one-time autologous TIL infusion, and a short course of high-dose IL-2.
- Conditions
- Metastatic Melanoma
- Being tested
- Lifileucel (LN-144)
- Keywords
- LN-144, Non-uveal melanoma, Lifileucel (LN-144), 22-322
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifileucel (LN-144)Biological
A portion of the patient's tumor is resected and serves as the starting material for manufacturing lifileucel. After preparative NMA-LD, patients are infused with their autologous TIL (lifileucel), followed by a short course of high-dose IL-2.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Melanoma Brain Metastases | Experimental | Participants have melanoma brain metastases who will undergo surgical excision to generate LN-144. Receives: Biological: Lifileucel (LN-144) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of treatment with LN-144 in patients with asymptomatic Metastatic Melanoma to the Brain (MMB)
measured by the number of patients who undergo surgery and successfully undergo LN-144 infusion
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start25 Nov 2022
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Iovance Biotherapeutics, Inc., Stanford University
- Responsible party
- Sponsor
- Investigators
- Alexander Shoushtari, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640193
- Sponsor's protocol ID
- 22-322
- Status last verified
- Sep 2026
- First submitted
- 28 Nov 2022
- Last updated
- 11 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Lifileucel (LN-144) for Patients With Asymptomatic Melanoma Brain Metastases and Progression on Prior PD1 Therapy
- ClinicalTrials.gov ID
- NCT05640193
- Acronym / sponsor ID
- 22-322
- Conditions
- Metastatic Melanoma
- Keywords
- LN-144, Non-uveal melanoma, Lifileucel (LN-144), 22-322
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Iovance Biotherapeutics, Inc., Stanford University
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label study evaluating lifileucel (LN-144) in patients with melanoma brain metastases.
Detailed description
Lifileucel (LN-144) is an autologous Tumor Infiltrating Lymphocytes (TIL) cell therapy that utilizes a 22-day centralized GMP process. Lifileucel is infused as part of a treatment regimen that includes preparative NMA-LD, followed by one-time autologous TIL infusion, and a short course of high-dose IL-2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Melanoma Brain Metastases | Experimental | Biological: Lifileucel (LN-144)Participants have melanoma brain metastases who will undergo surgical excision to generate LN-144. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Metastatic melanoma with asymptomatic brain metastases
- At least one resectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post-resection to generate TIL
- Must be ≥ 18 years of age at time of consent
- ECOG performance status of 0-1 and estimated life expectancy of ≥ 3 months
- Adequate hematologic parameters and organ function
Key exclusion criteria (11 listed)
- Received organ allograft, except kidney transplant, or prior cell transfer therapy including TIL and CAR-T therapies
- Ongoing grade 2-4 toxicity from prior immunotherapy (excluding endocrine, ocular toxicity or vitiligo)
- History of hypersensitivity to any component or excipient of lifileucel or other treatment regimen drugs
- Symptomatic brain metastases
- Chronic systemic steroid therapy of > 10 mg/day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifileucel (LN-144)A portion of the patient's tumor is resected and serves as the starting material for manufacturing lifileucel. After preparative NMA-LD, patients are infused with their autologous TIL (lifileucel), followed by a short course of high-dose IL-2. | Biological | Participants with Melanoma Brain Metastases |
Primary outcome
Feasibility of treatment with LN-144 in patients with asymptomatic Metastatic Melanoma to the Brain (MMB)
Time frame: 1 year
measured by the number of patients who undergo surgery and successfully undergo LN-144 infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Shoushtari, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lifileucel (LN-144) in people with Metastatic Melanoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of treatment with LN-144 in patients with asymptomatic Metastatic Melanoma to the Brain (MMB) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.