Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Memorial Sloan Kettering Cancer Center
With
Iovance Biotherapeutics, Inc.
Stanford University
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | A Study of LN-144 in People With Metastatic Melanoma to the Brain
