Expanded Access Program of Lifileucel (LN-144) in Patients With Unresectable or Metastatic Melanoma

This is an expanded access trial for Unresectable Melanoma focused on measuring LN-144, Lifileucel, Adoptive Cell Therapy, Cell Therapy, Tumor Infiltrating Lymphocytes, TIL, Immunotherapy, Melanoma, Cutaneous Melanoma, Mucosal Melanoma, Acral Melanoma Read More

Inclusion Criteria:

1. Unresectable or metastatic melanoma (Stages IIIC/IIID/IV per AJCC 8th edition)
2. Progressed on or did not achieve a response or were intolerant due to toxicity following 1-4 prior lines of systemic therapy including PD-1/ PD-L1 blocking antibody.
3. May have received adjuvant PD-1/PD-L1 blocking antibody if recurred within 6 months of discontinuation of therapy or while on therapy
4. At least one resectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post-resection to generate TIL
5. Must be ≥ 18 years of age at time of consent
6. ECOG performance status of 0-1 and estimated life expectancy of ≥ 3 months
7. Adequate hematologic parameters and organ function
8. There is no alternative therapy

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. Melanoma of uveal/ocular origin
4. History of hypersensitivity to any component or excipient of lifileucel or other treatment regimen drugs
5. Symptomatic and/or untreated brain metastases, unless definitively treated and stable for ≥ 14 days prior to beginning NMA LD preparative regimen
6. Chronic systemic steroid therapy of > 10 mg/day
7. Active medical illness(es) that would pose increased risk for protocol participation
8. 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
9. Primary immunodeficiency
10. Received live or attenuated vaccine within 28 days prior to beginning NMA-LD
11. Pregnant or breastfeeding