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CAR T-cell Therapy

Lifileucel for Metastatic Melanoma

Phase 1
Waitlist Available
Led By Allison Betof Warner, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status of 0-1 and estimated life expectancy of ≥ 3 months
Metastatic melanoma with asymptomatic brain metastases
Must not have
Chronic systemic steroid therapy of > 10 mg/day
Received organ allograft, except kidney transplant, or prior cell transfer therapy including TIL and CAR-T therapies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer treatment for people with melanoma that has spread to the brain.

Who is the study for?
This trial is for adults with metastatic melanoma that has spread to the brain but isn't causing symptoms. They should have at least one tumor big enough to be removed and used for treatment, be in fairly good health (able to perform daily activities), and not have serious illnesses or conditions that could make participating risky.
What is being tested?
The study is testing Lifileucel (LN-144), a therapy using cells from the patient's own immune system, on patients with melanoma that has spread to their brains. It's an open-label trial, meaning everyone knows they're getting this specific treatment.
What are the potential side effects?
While specific side effects of Lifileucel are not listed here, similar treatments can cause flu-like symptoms, fatigue, rash, fever, and may affect how organs like the liver and kidneys work. There might also be reactions where the cells are injected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am mostly active and doctors expect me to live for at least 3 more months.
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I have melanoma that has spread to my brain but I don't have symptoms.
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I have a tumor or tumors that can be surgically removed, totaling at least 1.5 cm in size.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I take more than 10 mg/day of steroids for a long-term condition.
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I have had an organ transplant (other than a kidney) or cell therapy like CAR-T.
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I am experiencing side effects from previous immunotherapy, except for hormone-related, eye issues, or skin color changes.
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I cannot have MRI scans with gadolinium contrast.
Select...
I have brain metastases that are causing symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of treatment with LN-144 in patients with asymptomatic Metastatic Melanoma to the Brain (MMB)
Secondary study objectives
Feasibility measured by the number of patients who undergo surgery and successfully undergo LN-144 infusion

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants with Melanoma Brain MetastasesExperimental Treatment1 Intervention
Participants have melanoma brain metastases who will undergo surgical excision to generate LN-144.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,979 Previous Clinical Trials
600,068 Total Patients Enrolled
Iovance Biotherapeutics, Inc.Industry Sponsor
25 Previous Clinical Trials
1,862 Total Patients Enrolled
Allison Betof Warner, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Alexander Shoushtari, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
49 Total Patients Enrolled

Media Library

Lifileucel (LN-144) (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05640193 — Phase 1
Skin Cancer Research Study Groups: Participants with Melanoma Brain Metastases
Skin Cancer Clinical Trial 2023: Lifileucel (LN-144) Highlights & Side Effects. Trial Name: NCT05640193 — Phase 1
Lifileucel (LN-144) (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05640193 — Phase 1
~3 spots leftby Nov 2025
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