Pilot Trial of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Patients With Metastatic Uveal Melanoma

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05607095

Collaborator

Iovance Biotherapeutics, Inc. (Industry)

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an open label study evaluating lifileucel (LN-144) in patients with metastatic uveal melanoma.

Condition or Disease	Intervention/Treatment	Phase
Uveal Melanoma Melanoma Metastatic Uveal Melanoma Metastatic Melanoma	Biological: Lifileucel (LN-144)	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pilot Trial of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Patients With Metastatic Uveal Melanoma

Actual Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Participants with Metastatic Uveal Melanoma Participants have metastatic uveal melanoma who will undergo surgical excision to generate LN-144	Biological: Lifileucel (LN-144) 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.

Arm

Intervention/Treatment

Experimental: Participants with Metastatic Uveal Melanoma

Participants have metastatic uveal melanoma who will undergo surgical excision to generate LN-144

Biological: Lifileucel (LN-144)

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.

Outcome Measures

Primary Outcome Measures

Adverse events as evaluated by CTCAE v5.0 [Up to 3 years]
Safety will be measured descriptively using CTCAE v5.0 for all patients who undergo surgical excision.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Metastatic uveal melanoma
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

Exclusion Criteria:

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 and/or untreated brain metastases
Chronic systemic steroid therapy of > 10 mg/day
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
Primary immunodeficiency
Received live or attenuated vaccine within 28 days prior to beginning NMA-LD
Pregnant or breastfeeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Westchester	Harrison	New York	United States	10604
2	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York	United States	10065