Autologous Killer Cell Therapy in Colon Cancer Patients

March 11, 2021 updated by: Naser Ahmadbeigi, Sabz Biomedicals

Safety and Efficacy of ex Vivo Activated and Expanded Autologous Cytokine-induced Killer Cells for Colon Cancer Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of
        • Recruiting
        • Gene Therapy Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of administering CIK cells plus chemotherapy
Time Frame: one month post infusion
Patients will be continually assessed for unexpected adverse events or unexpected early mortality 30 days post infusion
one month post infusion
Progression-free Survival (PFS)
Time Frame: 2 years
The time from treatment initiation day to first documented progressive disease or death due to disease.
2 years
Time to progression (TTP)
Time Frame: 2 years
the time from randomization until cancer progression, not including death.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 2 years
The length of time that the patients are still alive at a defined period of time after treatment
2 years
Patient quality of life
Time Frame: each 3 months for 2 years
Quality of patients enrolling in the study assessed using EORTC-CR29 questionnaire
each 3 months for 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sabz Biomedicals

Collaborators

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 9, 2020

Primary Completion (ANTICIPATED)

September 1, 2021

Study Completion (ANTICIPATED)

January 1, 2022

Study Registration Dates

First Submitted

October 30, 2017

First Submitted That Met QC Criteria

October 30, 2017

First Posted (ACTUAL)

November 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 15, 2021

Last Update Submitted That Met QC Criteria

March 11, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Autologous Killer cell therapy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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