Clinical trial · Interventional
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
NCT05640193CI-TRIAL-00095063active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Summary
Brief summary (as posted)
This is an open label study evaluating lifileucel (LN-144) in patients with melanoma brain metastases.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lifileucel (LN-144) | Biological | Lifileucel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Participants with Melanoma Brain Metastases
- description
- Participants have melanoma brain metastases who will undergo surgical excision to generate LN-144.
- interventionNames
- Biological: Lifileucel (LN-144)
Primary outcomes (1)
- measure
- Feasibility of treatment with LN-144 in patients with asymptomatic Metastatic Melanoma to the Brain (MMB)
- timeFrame
- 1 year
- description
- measured by the number of patients who undergo surgery and successfully undergo LN-144 infusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.