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Autologous Killer Cell Therapy in Colon Cancer Patients

Sponsor
Sabz Biomedicals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03329664
Collaborator
Ministry of Health and Medical Education (Other), Digestive Diseases Research Institute, Tehran University of Medical Sciences, Iran (Other)
20
Enrollment
1
Location
2
Arms
22.7
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Cytokine-induced killer cell
  • Other: Chemotherapy AND/OR Radiation Therapy
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Health Services Research
Official Title:
Safety and Efficacy of ex Vivo Activated and Expanded Autologous Cytokine-induced Killer Cells for Colon Cancer Patients
Actual Study Start Date :
Feb 9, 2020
Anticipated Primary Completion Date :
Sep 1, 2021
Anticipated Study Completion Date :
Jan 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: CIK Intervention plus routine treatment

Patients who receive their routine treatment (chemotherapy, radiation therapy) + Cytokine-induced killer cell infusion

Biological: Cytokine-induced killer cell
Immune-cell therapy with CIK cells
Other Names:
  • CIK

    • Other: Chemotherapy AND/OR Radiation Therapy
    Routine treatments for colon cancer patients according to their stage
    Active Comparator: Control

    Patients who receive routine treatments only (chemotherapy, radiation therapy)

    Other: Chemotherapy AND/OR Radiation Therapy
    Routine treatments for colon cancer patients according to their stage

    Outcome Measures

    Primary Outcome Measures

    1. Safety of administering CIK cells plus chemotherapy [one month post infusion]

      Patients will be continually assessed for unexpected adverse events or unexpected early mortality 30 days post infusion

    2. Progression-free Survival (PFS) [2 years]

      The time from treatment initiation day to first documented progressive disease or death due to disease.

    3. Time to progression (TTP) [2 years]

      the time from randomization until cancer progression, not including death.

    Secondary Outcome Measures

    1. Overall survival (OS) [2 years]

      The length of time that the patients are still alive at a defined period of time after treatment

    2. Patient quality of life [each 3 months for 2 years]

      Quality of patients enrolling in the study assessed using EORTC-CR29 questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    • History of positive test result for HIV, HBV, HCV, HTLV-1, syphilis

    • Presence of Active infections

    • Patients with immunodeficiencies, autoimmunities, or severe allergies

    • Receiving immunosuppressive regimens

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gene Therapy Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences Tehran Iran, Islamic Republic of

    Sponsors and Collaborators

    • Sabz Biomedicals
    • Ministry of Health and Medical Education
    • Digestive Diseases Research Institute, Tehran University of Medical Sciences, Iran

    Investigators

    • Principal Investigator: Naser Ahmadbeigi, Ph.D, Cell-based Therapies Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Naser Ahmadbeigi, Doctor, Tehran University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT03329664
    Other Study ID Numbers:
    • Autologous Killer cell therapy
    First Posted:
    Nov 6, 2017
    Last Update Posted:
    Mar 15, 2021
    Last Verified:
    Mar 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Colonic Neoplasms

    Study Results

    No Results Posted as of Mar 15, 2021