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Autologous Killer Cell Therapy in Colon Cancer Patients

Primary Purpose

Colon Cancer Stage IV

Status

Unknown status

Phase

Phase 1

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Cytokine-induced killer cell

Chemotherapy AND/OR Radiation Therapy

About this trial

This is an interventional health services research trial for Colon Cancer Stage IV

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CIK Intervention plus routine treatment

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Safety of administering CIK cells plus chemotherapy

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

Progression-free Survival (PFS)

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

Time to progression (TTP)

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

Secondary Outcome Measures

Overall survival (OS)

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

Patient quality of life

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

Full Information

NCT ID

NCT03329664

First Posted

October 30, 2017

Last Updated

March 11, 2021

Sponsor

Sabz Biomedicals

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03329664

Brief Title

Autologous Killer Cell Therapy in Colon Cancer Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Unknown status

Study Start Date

February 9, 2020 (Actual)

Primary Completion Date

September 2021 (Anticipated)

Study Completion Date

January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sabz Biomedicals

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colon Cancer Stage IV

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Non-Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CIK Intervention plus routine treatment

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Cytokine-induced killer cell

Other Intervention Name(s)

CIK

Intervention Description

Immune-cell therapy with CIK cells

Intervention Type

Other

Intervention Name(s)

Chemotherapy AND/OR Radiation Therapy

Intervention Description

Routine treatments for colon cancer patients according to their stage

Primary Outcome Measure Information:

Title

Safety of administering CIK cells plus chemotherapy

Description

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

Time Frame

one month post infusion

Title

Progression-free Survival (PFS)

Description

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

Time Frame

2 years

Title

Time to progression (TTP)

Description

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

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Overall survival (OS)

Description

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

Time Frame

2 years

Title

Patient quality of life

Description

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

Time Frame

each 3 months for 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Naser Ahmadbeigi, Ph.D

Phone

+9821-82415103

n-ahmadbeigi@sina.tums.ac.ir

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Naser Ahmadbeigi, Ph.D

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Tehran

Country

Iran, Islamic Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Naser Ahmadbeigi, Phd

Phone

09129155066

ahmadbeigi28@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Autologous Killer Cell Therapy in Colon Cancer Patients

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