NCT05040568

A PHASE IB STUDY OF IMMUNOTHERAPY WITH EX VIVO PRE-ACTIVATED AND EXPANDED CB-NK CELLS IN COMBINATION WITH CETUXIMAB, IN COLORECTAL CANCER PATIENTS WITH MINIMAL RESIDUAL DISEASE (MRD)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Colon Cancer
• Resected Stage

Interventions

Type	Name	Description
DRUG	Cetuximab	Given IV
DRUG	Expanded CB-NK cells	Given IV
DRUG	Fludarabine phosphate	Given IV
DRUG	Cyclophosphamide	Given IV

Timeline

• Start date: 2022-02-28
• Primary completion: 2026-01-15
• Completion: 2026-01-15
• First posted: 2021-09-10
• Last updated: 2026-01-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study