NCT03554889

Immunotherapy of Advanced Cancer Using a Combination Nimotuzumab and NK Cells

A Phase I Trial of Combined Nimotuzumab With NK Cells Adoptive Transfer for the Treatment of Advanced Cancer

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Hangzhou Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

NK cells can persist and expand in vivo following adoptive transfer and may have a role in the treatment of late stage malignancies. NK also express an activating Fc receptor that mediates antibody-dependent cellular cytotoxicity (ADCC) and production of immune modulatory cytokines in response to antibody-coated targets. Nimotuzumab, an monoclonal antibody against EGFR (epidermal growth factor receptor), may enhance the ADCC effect of NK cell. This study will evaluate the safety of combination of nimotuzumab and NK Cell in treating advanced cancer patients. Blood samples will also be collected for research purposes.

Detailed description

This is a phase I clinical study of expanded NK cells from autologous origin. The NK cell will be selected and expanded ex vivo and infused back into patients. Nimotuzumab will be used 24 hours before infusion. 21 advanced cancer patients are planned to receive two cycles of NK cells and Nimotuzumab treatment. Biomarkers and immunological markers are collected and analyzed as well.

Conditions

• Advanced Cancer
• ADCC
• NK Cell Mediated Immunity
• Nimotuzumab
• Adaptive Transfer

Interventions

Type	Name	Description
BIOLOGICAL	NK Cell adaptive transfer	Nimotuzumab will enhance the ADCC effect of NK Cell adaptive transfer
DRUG	Nimotuzumab	Nimotuzumab will enhance the ADCC effect of NK Cell adaptive transfer

Timeline

• Start date: 2018-08-01
• Primary completion: 2019-03-30
• Completion: 2019-11-27
• First posted: 2018-06-13
• Last updated: 2018-06-13

Locations

1 site across 1 country: China