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Virus Therapy

Immunotherapy + Cetuximab for Colon Cancer

Phase 1

Waitlist Available

Led By Maria Morelli

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has resected stage IV colorectal cancer undergone with curative intent, has completed standard-of-care adjuvant- and/or neo-adjuvant treatment with no evidence of residual disease but has persistent ctDNA in the bloodstream

Has ECOG performance status of 0-1

Must not have

Had treatment with therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to initiation of study treatment

Has active tuberculosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial will test a new immunotherapy treatment for people with colon cancer who have ctDNA.

Who is the study for?

Adults with high-risk stage II or III colorectal cancer who've finished standard treatment and show no relapse but have ctDNA in their blood, or those with resected stage IV treated with curative intent. Participants must be healthy enough for the trial, not pregnant, without severe allergies to certain antibodies or components of the therapy, free from other cancers within 5 years, and not recently treated with similar drugs.

What is being tested?

The study tests a combination of immunotherapy using CB-NK cells pre-activated and expanded ex vivo along with cetuximab against minimal residual disease in colon cancer patients. It aims to see if this can target remaining cancer indicated by circulating tumor DNA (ctDNA) after primary treatment.

What are the potential side effects?

Possible side effects include allergic reactions to cetuximab or cell therapy ingredients, infection risks due to immune system changes caused by NK cells and cetuximab, potential organ inflammation from immune responses, as well as general discomfort like fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had surgery for stage IV colorectal cancer, finished all treatments, have no visible cancer left, but still have cancer DNA in my blood.

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I am fully active or can carry out light work.

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I am 18 years old.

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My blood and organ tests meet the required health standards.

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I have high-risk stage II or III colorectal cancer, finished treatment, no signs of relapse, but still have ctDNA.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not taken any antibiotics by mouth or IV in the last 2 weeks.

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I have active tuberculosis.

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I have a serious heart condition.

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I have taken immunosuppressive medication recently.

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I haven't had cancer treatment in the last 28 days.

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I have not had a severe infection in the last 4 weeks.

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I have an active hepatitis C infection.

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I have an active hepatitis B infection.

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I have a history of lung conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2012 Phase 3 trial • 73 Patients • NCT01177956

43%

Leucopenia

43%

Weight Decreased

40%

Nausea

35%

Rash

34%

Hypomagnesaemia

32%

Hypokalemia

31%

Constipation

28%

Vomiting

28%

Neutropenia

26%

Decreased Appetite

22%

Pyrexia

19%

Hyponatremia

19%

Acne

19%

Hemoglobin Decreased

18%

Stomatitis

18%

Diarrhea

15%

Fatigue

15%

Pruritus

13%

Mucosal Inflammation

13%

Neutrophil Count Decreased

12%

Mouth Ulceration

10%

Insomnia

10%

Thrombocytopenia

10%

Asthenia

Dizziness

Cough

White Blood Cell Count Decreased

Hypocalcaemia

Dermatitis Acneiform

Hypochloremia

Abdominal Pain Upper

Paronychia

Aspartate Aminotransferase Increased

Weight Increased

Neck pain

Dyspnoea

Oral Pain

Headache

Anaphylactic reaction

Microcytic anemia

Mouth hemorrhage

Staphylococcal skin infection

Tumor hemorrhage

Pneumonia

Electrolyte imbalance

Myocardial infarction

Pneumonitis

Pulmonary embolism

Respiratory alkalosis

Toxic encephalopathy

Venous thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

Cetuximab + Cisplatin + 5-FU : Treatment Emergent Phase

Cetuximab + Cisplatin + 5-FU : Late Phase

Trial Design

1Treatment groups

Experimental Treatment

Group I: CetuximabExperimental Treatment4 Interventions

given to patients with high-risk colorectal cancer

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cetuximab

2011

Completed Phase 3

~2480

Fludarabine phosphate

2007

Completed Phase 2

~370

Cyclophosphamide

2010

Completed Phase 4

~2320

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

3,039 Previous Clinical Trials

1,799,686 Total Patients Enrolled

Maria MorelliPrincipal InvestigatorM.D. Anderson Cancer Center

~7 spots leftby Feb 2027

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