RecruitingPhase 1NCT05629546

Memory-Like Natural Killer Cells With Nivolumab and Relatlimab in Advanced or Metastatic Melanoma After Progression on Checkpoint Inhibitors

Phase I Study of Memory-Like Natural Killer Cells With Nivolumab and Relatlimab in Advanced or Metastatic Melanoma After Progression on Checkpoint Inhibitors


Sponsor

Washington University School of Medicine

Enrollment

33 participants

Start Date

Nov 6, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 1 open-label, study designed to characterize the safety, tolerability, and preliminary anti-tumor activity of memory-like natural killer cells (ML NK) in combination with nivolumab and relatlimab in subjects with advanced and/or metastatic melanoma. There will be two arms to test the variables of ML NK cell source. ML NK cells from an autologous source will be used for Arm 1, and ML NK cells from an allogeneic source will be used for Arm 2. The investigators hypothesize that ML NK cells from either an autologous source or allogeneic source are safe and tolerable in subjects with advanced and/or metastatic melanoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a novel immune cell therapy using specially activated natural killer (NK) cells — a type of immune cell — combined with two immunotherapy drugs (nivolumab and relatlimab) for people with advanced melanoma whose cancer progressed despite previous immunotherapy. The goal is to re-engage the immune system against a tumor that has become resistant. **You may be eligible if...** - You are 18 or older with advanced or metastatic melanoma confirmed by biopsy - Your cancer progressed after at least 12 weeks (or 2 doses) of a standard PD-1 immunotherapy (such as nivolumab or pembrolizumab) - Your general health is reasonably good (ECOG ≤2) - Your organ function (liver, kidneys, heart) meets the required thresholds - Your expected survival is more than 12 weeks **You may NOT be eligible if...** - You have an active autoimmune disease requiring immunosuppression - You have had a prior severe immune-related side effect (grade 3 or 4) from cancer immunotherapy (some exceptions apply) - You cannot come off corticosteroids or immunosuppressants for the required period before treatment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCytokine-induced memory-like natural killer cells

Cell product processing is performed at the Siteman Cancer Center Biological Therapy Core Facility (BTCF).

BIOLOGICALRelatilmab

Standard of care

BIOLOGICALNivolumab

Standard of care


Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT05629546


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