← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am mostly active and doctors expect me to live for at least 3 more months.

Select...

I have melanoma that has spread to my brain but I don't have symptoms.

Select...

I have a tumor or tumors that can be surgically removed, totaling at least 1.5 cm in size.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of treatment with LN-144 in patients with asymptomatic Metastatic Melanoma to the Brain (MMB)

Secondary outcome measures

Feasibility measured by the number of patients who undergo surgery and successfully undergo LN-144 infusion

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,610 Total Patients Enrolled

76 Trials studying Melanoma

15,968 Patients Enrolled for Melanoma

Iovance Biotherapeutics, Inc.Industry Sponsor

20 Previous Clinical Trials

1,686 Total Patients Enrolled

9 Trials studying Melanoma

949 Patients Enrolled for Melanoma

Allison Betof Warner, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Lifileucel (LN-144) (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05640193 — Phase 1

Melanoma Research Study Groups: Participants with Melanoma Brain Metastases

Melanoma 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open spots remaining in this study?

"Affirmative, according to the information present on clinicaltrials.gov this trial is actively searching for eligible applicants. It initially went live on November 25th 2022 and was updated most recently on the 28th of that same month. 10 patients need to be identified from 1 medical centre."

Answered by AI

What is the approximate number of participants for this research project?

"Affirmative, clinicaltrials.gov data indicates that this research is in search of volunteers. This trial was first posted on November 25th 2022 and had its most recent update a few days later on the 28th. 10 participants are needed from one study centre for enrollment into the program."

Answered by AI

Has Lifileucel (LN-144) obtained regulatory clearance from the FDA?

"Our analysis at Power has placed the safety of Lifileucel (LN-144) at 1, as this Phase 1 trial only carries a modicum of data backing its efficacy and security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of LN-144 in People With Metastatic Melanoma to the Brain

2022. "A Study of LN-144 in People With Metastatic Melanoma to the Brain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05640193.