Autologous Killer Cell Therapy in Colon Cancer Patients

  • STATUS
    Recruiting
  • End date
    Jan 21, 2022
  • participants needed
    20
  • sponsor
    Sabz Biomedicals
Updated on 21 March 2021

Summary

This study aims to evaluate the safety and efficacy of activated and expanded autologous cytokine-killer cells in controlling disease recurrence in colon cancer patients with liver metastasis. 20 patients with confirmed stage IV colon carcinoma with metastasis will be assigned into two groups. Patients in both groups will receive the same therapeutic regimen as usual. Patients in one group additionally will be treated with a single infusion of autologous killer cells that had been previously prepared from peripheral blood.

Details
Condition Metastatic Colon Cancer, Colon Cancer Stage II/III, Colon Cancer Stage II/III, Colon Cancer Stage II/III
Treatment Cytokine-induced killer cell, Chemotherapy AND/OR Radiation Therapy
Clinical Study IdentifierNCT03329664
SponsorSabz Biomedicals
Last Modified on21 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 40 yrs and 60 yrs?
Are you male?
Do you have Colon Cancer Stage II/III?
Do you have any of these conditions: Do you have Colon Cancer Stage II/III??
Do you have any of these conditions: Do you have Colon Cancer Stage II/III??
Is your age greater than or equal to 40 yrs?
Gender: Male or Female
Do you have any of these conditions: Metastatic Colon Cancer or Colon Cancer Stage II/III?
Is your age greater than or equal to 40 yrs?
Gender: Male or Female
Do you have any of these conditions: Colon Cancer Stage II/III or Metastatic Colon Cancer?
Is your age greater than or equal to 40 yrs?
Gender: Male or Female
Do you have any of these conditions: Colon Cancer Stage II/III or Metastatic Colon Cancer?
Patients with histologically confirmed colorectal cancer at stage IV
ECOG performance status 0-2
Adequate cardiac/renal/hepatic function
Adequate bone marrow function (blood cell count)

Exclusion Criteria

Patients that have received prior chemotherapy or immune cell therapy
Patients that have previously participated in another clinical trial
Patients with immunodeficiencies, autoimmunities, or severe allergies
History of positive test result for HIV, HBV, HCV, HTLV-1, syphilis
Presence of Active infections
Receiving immunosuppressive regimens
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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