Autologous Killer Cell Therapy in Colon Cancer Patients

NCT ID: NCT03329664

Last Updated: 2021-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-09

Study Completion Date

2022-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colon Cancer Stage IV

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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CIK Intervention plus routine treatment

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

Group Type EXPERIMENTAL

Cytokine-induced killer cell

Intervention Type BIOLOGICAL

Immune-cell therapy with CIK cells

Chemotherapy AND/OR Radiation Therapy

Intervention Type OTHER

Routine treatments for colon cancer patients according to their stage

Control

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

Group Type ACTIVE_COMPARATOR

Chemotherapy AND/OR Radiation Therapy

Intervention Type OTHER

Routine treatments for colon cancer patients according to their stage

Interventions

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Cytokine-induced killer cell

Immune-cell therapy with CIK cells

Intervention Type BIOLOGICAL

Chemotherapy AND/OR Radiation Therapy

Routine treatments for colon cancer patients according to their stage

Intervention Type OTHER

Other Intervention Names

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CIK

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health and Medical Education

UNKNOWN

Sponsor Role collaborator

Digestive Diseases Research Institute, Tehran University of Medical Sciences, Iran

UNKNOWN

Sponsor Role collaborator

Sabz Biomedicals

INDUSTRY

Sponsor Role lead

Responsible Party

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Naser Ahmadbeigi

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Naser Ahmadbeigi, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Cell-based Therapies Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran

Locations

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Gene Therapy Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences

Tehran, , Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Naser Ahmadbeigi, Ph.D

Role: CONTACT

+9821-82415103

Facility Contacts

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Naser Ahmadbeigi, Phd

Role: primary

09129155066

Other Identifiers

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Autologous Killer cell therapy

Identifier Type: -

Identifier Source: org_study_id

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