NCT05640193Active, not recruitingPhase 1
A Study of LN-144 in People With Metastatic Melanoma to the Brain
Pilot Trial of Lifileucel (LN-144) for Patients With Asymptomatic Melanoma Brain Metastases and Progression on Prior PD1 Therapy
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
This is an open label study evaluating lifileucel (LN-144) in patients with melanoma brain metastases.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 28 Nov 2022
- Start date
- 25 Nov 2022
- Primary completion date
- Nov 2027
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Melanoma
- NCT number
- NCT05640193
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 10
- From 25 Nov 2022 to the primary completion date, Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Chronic systemic steroid therapy of \> 10 mg/day
- Received live or attenuated vaccine within 28 days prior to beginning NMA-LD
Other illness
- History of hypersensitivity to any component or excipient of lifileucel or other treatment regimen drugs
- Active medical illness(es) that would pose increased risk for protocol participation
- 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
Other
- Symptomatic brain metastases
- Primary immunodeficiency
- Pregnant or breastfeeding
- Patients who cannot receive gadolinium-enhanced MRI.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.