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)

NCT05040568 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: 2021-0076NCI-2021-09411
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Colon Cancer; Resected Stage

Outcome Measures

Primary Outcomes (1)

• The activity of the CB-NK infusion in combination with cetuximab in patients with resected colorectal cancer and positivity for minimal residual disease

  through study completion, an average of 1 year

Study Arms (1)

Cetuximab

EXPERIMENTAL

given to patients with high-risk colorectal cancer

Drug: Cetuximab; Drug: Expanded CB-NK cells; Drug: Fludarabine phosphate; Drug: Cyclophosphamide

Interventions

Cetuximab DRUG

Given IV

Also known as: C225, Erbituxâ"¢, IMC-C225, MOAB C225

Cetuximab

Expanded CB-NK cells DRUG

Given IV

Cetuximab

Fludarabine phosphate DRUG

Given IV

Also known as: Fludarabine, Fludara®

Cetuximab

Cyclophosphamide DRUG

Given IV

Also known as: Cytoxan®, Neosar®

Cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has high-risk stage II or stage III colorectal cancer and has completed standard-of-care treatment, including complete disease resection followed by standard-of-care adjuvant treatment and has no evidence of relapsing disease per the CT scan but has persistent ctDNA in the bloodstream; OR has resected stage IV colorectal cancer undergone with curative intent, has completed standard-of-care adjuvant- and/or neo-adjuvant treatment, and has no evidence of residual disease per the CT scan but has persistent ctDNA in the bloodstream.
• Has signed the Informed Consent Form
• Is age ≥ 18 years
• Is able to comply with the study protocol, in the investigator's judgment
• Has ECOG performance status of 0-1
• Has adequate hematologic and end-organ function defined by the following laboratory test results obtained within 28 days prior to initiation of study treatment:
• Absolute neutrophil count (ANC) ≥ 1,500/mm3 without granulocyte colony-stimulating factor support
• Lymphocyte count ≥ 500/mm3
• Platelet count ≥ 100,000/mm3 without transfusion
• White blood cell count ≥ 2,500/mm3
• Hemoglobin ≥ 9.0 g/dL o Patients may be transfused to meet this criterion.
• Aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase ≥ 2.5 x upper limit of normal (ULN), with the following exceptions:
• For patients with documented liver metastases: AST and ALT ≤ 5 x ULN
• For patients with documented liver or bone metastases: alkaline phosphatase ≤ 5 x ULN
• Serum bilirubin ≤ 1.5 x ULN with the following exception:

You may not qualify if:

• Received treatment for the studied cancer within 28 days prior to initiation of study treatment
• Received treatment with an investigational therapy within 28 days prior to initiation of study treatment
• Has a history of severe allergic-, anaphylactic-, or other hypersensitivity reactions to chimeric- or humanized antibodies or fusion proteins
• Has a known hypersensitivity to biopharmaceutical agents produced in Chinese hamster ovary cells
• Has a known allergy or hypersensitivity to any component of the expanded CB-NK cells formulation
• Has a known allergy or hypersensitivity to any component of the cetuximab formulation
• Has active- or a history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:
• Patients with a history of autoimmune-related hypothyroidism who are on thyroid- replacement hormone are eligible for the study.
• Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
• Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:
• Rash must cover \<10% of body surface area
• Disease is well controlled at baseline and requires only low-potency topical corticosteroids
• No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12 months
• Had prior allogeneic stem cell or solid organ transplantation
• Has history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Cetuximab; fludarabine phosphate; fludarabine; Cyclophosphamide

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Maria Morelli

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: September 10, 2021
• Study Start: February 28, 2022
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

US (1)