Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2025-12-24 @ 5:46 PM
NCT ID:
NCT05040568
Brief Summary:
A study of immunotherapy with expanded CB-NK cells in combination with cetuximab, to evaluate activity against minimal residual disease in patients with colon cancer that have completed adjuvant treatment but are positive for ctDNA
Detailed Description:
This is a Phase Ib clinical trial to evaluate the safety and activity of expanded CB-NK cells in combination with cetuximab in patients with high-risk CRC who have completed adjuvant chemotherapy but are still positive for MRD (see Figure 5). A total of 15 patients with stage II-III, and resected stage IV CRC and positivity for MRD will be enrolled. MRD is defined as the lack of radiographically evident disease, in the presence of ctDNA matching the original tumor mutations after adjuvant chemotherapy. The primary goal of the study is ctDNA clearance from the blood in these patients. After completing SOC surgery and adjuvant chemotherapy, patients will be tested for the persistence of blood ctDNA. Those who are ctDNA-positive will repeat a computed tomography (CT) scan and if the imaging shows no radiological evidence of disease, they will be eligible for the study screening.
Primary Objective:
• To evaluate the activity of the CB-NK infusion in combination with cetuximab in patients with resected colorectal cancer and positivity for minimal residual disease
Secondary Objective:
• To evaluate the efficacy of the CB-NK infusion in combination with cetuximab in patients with resected colorectal cancer and positivity for minimal residual disease
Study:
NCT05040568
Study Brief:
Protocol Section:
NCT05040568