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)

Completed · Phase 1

Conditions studied: Colon Cancer, Resected Stage

In brief

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

Key facts

Study ID

NCT05040568

Run by

M.D. Anderson Cancer Center

People needed

15

Starts

2022-02-28

Expected to finish

2026-01-15

Last updated by the study team

2026-01-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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:
• o For patients with known Gilbert disease: serum bilirubin level ≤ 3 x ULN
• Serum creatinine ≤ 1.5 x ULN
• Serum albumin ≥ 2.5 g/dL
• For patients not receiving therapeutic anticoagulation: international normalized ratio (INR) or activated partial thromboplastin time (aPTT) ≤1.5 x ULN
• Adequate cardiac function
• Baseline EKG and echocardiogram (ECHO) within normal limits
• For women and men for childbearing potential: agreement to use a contraceptive method with a failure rate of <1% per year or remain abstinent (refrain from heterosexual intercourse) during the treatment period and for 6 months after the last dose of study treatment
• A woman is considered to be of childbearing potential if she is premenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).
• Examples of contraceptive methods with a failure rate of <1% per year include bilateral tubal ligation, male sterilization, barrier method, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
• The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.

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
• History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
• Had a positive HIV test at screening
• Has active hepatitis B virus (HBV) infection (chronic or acute), defined as having a positive hepatitis B surface antigen (HBsAg) test at screening
• Patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test and negative HBV DNA test at screening, are eligible for the study.
• Has active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test followed by a positive HCV RNA test at screening
• The HCV RNA test will be performed only for patients who have a positive HCV antibody test.
• Has active tuberculosis
• Had a severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
• Had treatment with therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to initiation of study treatment
• Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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