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CAR T-cell Therapy

Lifileucel for Uveal Melanoma

Phase 1
Recruiting
Led By Alexander Shoushtari, MD
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
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Patients must be ≥ 18 years of age at the time of consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial tests a new drug to treat metastatic eye cancer.

Who is the study for?
This trial is for adults over 18 with metastatic uveal melanoma, who have at least one lesion suitable for TIL harvesting. Participants must not be pregnant or breastfeeding, free from certain infections and systemic illnesses, not on immunosuppressive therapy (except steroids for adrenal insufficiency), and without a history of organ transplant or cell transfer therapy.Check my eligibility
What is being tested?
The study is testing lifileucel (LN-144) in patients with metastatic uveal melanoma. It's an open-label pilot trial, meaning both the researchers and participants know what treatment is being given. The focus is on evaluating the safety and effectiveness of LN-144 derived from the patient's own tumor cells.See study design
What are the potential side effects?
While specific side effects are not listed here, treatments like LN-144 can cause immune-related reactions due to enhanced activity against cancer cells that may also affect normal cells. This can lead to inflammation in various organs, fatigue, flu-like symptoms, allergic reactions to infusion components, and potential infection risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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I am 18 years old or older.
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My cancer is a type of eye melanoma that has spread.
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My liver and kidneys are functioning well.
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I am 18 years old or older.
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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 mostly active and doctors expect me to live for at least 3 more months.
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I have been diagnosed with metastatic Uveal Melanoma.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse events as evaluated by CTCAE v5.0

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants with Metastatic Uveal MelanomaExperimental Treatment1 Intervention
Participants have metastatic uveal melanoma who will undergo surgical excision to generate LN-144

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,935 Previous Clinical Trials
588,851 Total Patients Enrolled
Iovance Biotherapeutics, Inc.Industry Sponsor
20 Previous Clinical Trials
1,686 Total Patients Enrolled
Alexander Shoushtari, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
3 Previous Clinical Trials
39 Total Patients Enrolled

Media Library

Lifileucel (LN-144) (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05607095 — Phase 1
Uveal Melanoma Research Study Groups: Participants with Metastatic Uveal Melanoma
Uveal Melanoma Clinical Trial 2023: Lifileucel (LN-144) Highlights & Side Effects. Trial Name: NCT05607095 — Phase 1
Lifileucel (LN-144) (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05607095 — Phase 1

Frequently Asked Questions

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

Has the FDA given its approval to treatments for metastatic uveal melanoma?

"Because our team has limited data on the safety and efficacy of Participants with Metastatic Uveal Melanoma, this trial received a score of 1."

Answered by AI

How many participants are registered for this experiment?

"Yes, the evidence on clinicaltrials.gov establishes that this research project is still recruiting participants. It was initially posted on November 1st 2022 and its data was most recently updated in early November of 2021: 10 patients need to be enrolled from 2 locations."

Answered by AI

Is there currently any recruitment occurring for this experiment?

"The clinical trial is presently recruiting, as detailed on the official listing hosted by ClinicalTrials.gov. This medical study was initially posted to the website on November 1st 2022 and it has been revised most recently on November 8th 2022."

Answered by AI

Who else is applying?

What state do they live in?
New York
What site did they apply to?
Memorial Sloan Kettering Westchester
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Pilot Trial of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Patients With Metastatic Uveal Melanoma
2022. "Pilot Trial of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Patients With Metastatic Uveal Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05607095.
~0 spots leftby May 2024
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