drugset / Trial / NCT05629546
Memory-Like Natural Killer Cells With Nivolumab and Relatlimab in Advanced or Metastatic Melanoma After Progression on Checkpoint Inhibitors
Phase 1
Recruiting
33 enrolled
Washington University School of Medicine
Melanoma Research Alliance · collabRising Tide Foundation · collab
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-11-06
- Primary completion
- 2029-02-28
- Completion
- 2030-11-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CIML-NK Cells | Cell therapy | — | Intravenous |
| Background | Nivolumab | Monoclonal antibody | — | — |
| Background | Relatlimab | Monoclonal antibody | — | — |