Trials / Completed
CompletedNCT03941262
Safety of SNK01 in Subjects With Pathologically Confirmed Metastatic and/or Unresectable Cancer Refractory to Conventional Therapy
Phase 1, Open-Label, Safety Study of Escalating Doses of Ex Vivo Expanded, Autologous Natural Killer Cells in Patients With Pathologically Confirmed Cancer Refractory to Conventional Therapy
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- NKGen Biotech, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the safety and preliminary efficacy of SNK01 (autologous natural killer cell), as a single agent and in combination with avelumab or pembrolizumab, for the treatment of subjects with advanced and/or metastatic refractory cancer that has failed three or more prior lines of conventional standard of care therapy.
Conditions
- Refractory Cancer
- Metastatic Cancer
- Recurrent Cancer
- Unresectable Carcinoma
- Solid Tumor, Adult
- Advanced Cancer
- Advanced Solid Tumor
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SNK01 | Patient-specific ex vivo expanded autologous natural killer cells |
| DRUG | Avelumab | Avelumab is a humanized monoclonal antibody immune checkpoint blockade immunotherapy that targets the programmed cell death-ligand 1 (PD-L1). |
| DRUG | Pembrolizumab | Pembrolizumab is a humanized monoclonal antibody immune checkpoint blockade immunotherapy that targets the programmed cell death receptor-1 (PD-1). |
Timeline
- Start date
- 2019-07-15
- Primary completion
- 2023-02-17
- Completion
- 2023-02-17
- First posted
- 2019-05-07
- Last updated
- 2023-11-13
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03941262. Inclusion in this directory is not an endorsement.