Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2026-01-01 @ 6:55 AM
Study NCT ID:
NCT05040568
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-13
First Post:
2021-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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)
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
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:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2021-09411 | OTHER | NCI-CTRP Clinical Trials Reporting Registry | View |