What side effects are associated with this type of intervention?

Adoptive cell therapy using tumor-infiltrating lymphocytes (TILs), such as Lifileucel (LN-144), can lead to several side effects. Commonly reported adverse effects include cytokine release syndrome, which can cause fever, fatigue, and low blood pressure. Other potential side effects are related to the preparative lymphodepletion regimen, which may include nausea, vomiting, and increased risk of infections due to immunosuppression. Additionally, patients may experience autoimmune-like symptoms due to the activation of immune cells. For broader treatments of uveal melanoma, side effects from therapies like chemotherapy, radiation, and targeted therapies can include ocular irritation, visual disturbances, and systemic effects such as fatigue and gastrointestinal issues.

What prior FDA approvals exist?

There is no specific information provided about prior FDA approvals for treatments of uveal melanoma that are similar to Lifileucel (LN-144). Generally, treatments for uveal melanoma have included options like surgery, radiation therapy, and systemic therapies such as chemotherapy and immunotherapy. Adoptive cell therapy using tumor-infiltrating lymphocytes, as studied in the trial for Lifileucel (LN-144), represents a novel approach in this context.

What other types of research exist?

Promising alternatives to Lifileucel (LN-144) for Uveal Melanoma patients include immune checkpoint inhibitors such as pembrolizumab and nivolumab, which have shown efficacy in various melanoma subtypes. Additionally, targeted therapies like tebentafusp, a bispecific fusion protein, have demonstrated significant clinical benefits in recent trials. These options represent novel and effective treatments for Uveal Melanoma.

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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

Must not have

Patients who have received an organ allograft or prior cell transfer therapy that included a non-myeloablative or myeloablative chemotherapy regimen

Patients with symptomatic brain metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing lifileucel, a treatment that uses a patient's own immune cells, in patients with advanced uveal melanoma. The treatment aims to boost the body's natural ability to fight cancer. Lifileucel has shown promising results in treating melanoma that does not respond to other treatments.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had an organ transplant or cell therapy with strong chemotherapy.

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I have brain metastases that are causing symptoms.

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I have had another type of cancer in the last 3 years.

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I haven't had a live vaccine in the last 28 days.

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I am not on long-term immune-weakening drugs, except for steroids for adrenal issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse events as evaluated by CTCAE v5.0

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment 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/LN-145

Group II: Participants with Metastatic SarcomaExperimental Treatment1 Intervention

Participants have metastatic sarcoma who will undergo surgical excision to generate LN-144/LN-145

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Lifileucel (LN-144) is an adoptive cell therapy that uses tumor-infiltrating lymphocytes (TILs) to target and destroy cancer cells. The mechanism involves extracting TILs from the patient's tumor, expanding them in a laboratory, and then re-infusing them into the patient. These TILs are naturally primed to recognize and attack tumor cells, enhancing the body's immune response against the cancer. This approach is significant for Uveal Melanoma patients because it offers a personalized treatment option that leverages the patient's own immune system to combat a cancer that is often resistant to conventional therapies.