A New Treatment Using Your Own Immune Cells to Fight Melanoma That Has Spread to the Brain
Pilot Trial of Lifileucel (LN-144) for Patients With Asymptomatic Melanoma Brain Metastases and Progression on Prior PD1 Therapy
In Plain English
This trial tests a treatment called lifileucel (LN-144) for people with uveal melanoma that has spread to the brain and stopped responding to standard immunotherapy drugs (PD-1 inhibitors). Here's how it works: doctors remove a small piece of your tumor, then send it to a lab where they grow special immune cells called TILs (tumor-infiltrating lymphocytes) — these are your own white blood cells that were already fighting your cancer. Over about 3 weeks, the lab multiplies these cells so there are billions of them. Then they put them back into your body through an IV infusion. You'll also receive a mild chemotherapy preparation beforehand and a short course of a drug called IL-2 afterward to help these cells work better. This is an early-stage trial (Phase 1), which means doctors are still learning if this approach is safe and effective for brain metastases. You'll need to stay in the hospital for several weeks during treatment. This trial is for people whose cancer has spread to the brain but isn't causing symptoms yet, and whose previous immunotherapy treatments stopped working.
What This Trial Does
This is an open label study evaluating lifileucel (LN-144) in patients with melanoma brain metastases.
How It Works
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.
Who Can Join
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.
Treatments
Lifileucel (LN-144) (BIOLOGICAL)
A portion of the patient's tumor is resected and serves as the starting material for manufacturing lifileucel. After preparative NMA-LD, patients are infused with their autologous TIL (lifileucel), followed by a short course of high-dose IL-2.
Trial Sites (1)
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States