NCT05990920

Study of Allogeneic Blood-derived Natural Killer Cells to Evaluate Safety and Tolerability in Cancer Refractory to Conventional Therapy

A Phase 1, Open-Label, Dose Escalation Study of Allogeneic Blood-derived Natural Killer Cells to Evaluate Safety and Tolerability in Participants with Pathologically Confirmed Cancer Refractory to Conventional Therapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: NKGen Biotech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to test SNK02 in participants with pathologically confirmed cancer that is refractory to conventional therapy. The main questions it aims to answer are: * Is SNK02 safety and tolerable when administered weekly as an intravenous infusion * What is the maximum dose that is tolerated of SNK02 Participants will be administered SNK02 weekly for 8 weeks and undergo medical evaluation to provide initial clinical safety data for the treatment of cancer with allogeneic NK cells as a monotherapy treatment.

Conditions

• Pathologically Confirmed Cancer Refractory to Conventional Therapy
• Refractory Cancer
• Metastatic Cancer
• Recurrent Cancer
• Solid Tumor, Adult
• Solid Tumor
• Advanced Cancer
• Advanced Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	SNK02	SNK02 is ex vivo expanded allogeneic NK cells for IV injection, is a light-yellow cryopreserved cell suspension consisting of NK cells isolated from healthy donor's peripheral blood mononuclear cells.

Timeline

• Start date: 2023-08-23
• Primary completion: 2024-04-12
• Completion: 2024-04-12
• First posted: 2023-08-14
• Last updated: 2024-11-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study