NCT05629546

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Melanoma
• Metastatic Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	Cytokine-induced memory-like natural killer cells	Cell product processing is performed at the Siteman Cancer Center Biological Therapy Core Facility (BTCF).
BIOLOGICAL	Relatilmab	Standard of care
BIOLOGICAL	Nivolumab	Standard of care

Timeline

• Start date: 2024-11-06
• Primary completion: 2029-02-28
• Completion: 2030-11-30
• First posted: 2022-11-29
• Last updated: 2025-09-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study