Autologous Killer Cell Therapy in Colon Cancer Patients

Colon Cancer Stage IV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03329664
• Other study ID #: Autologous Killer cell therapy
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 9, 2020
• Est. completion date: January 2022

Study information

• Verified date: March 2021
• Source: Sabz Biomedicals
• Contact: Naser Ahmadbeigi, Ph.D
• Phone: +9821-82415103
• Email: n-ahmadbeigi[@]sina.tums.ac.ir
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2022
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer Stage IV
• Colonic Neoplasms

Intervention

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

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Gene Therapy Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences	Tehran

Sponsors (3)

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

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of administering CIK cells plus chemotherapy	Patients will be continually assessed for unexpected adverse events or unexpected early mortality 30 days post infusion	one month post infusion
Primary	Progression-free Survival (PFS)	The time from treatment initiation day to first documented progressive disease or death due to disease.	2 years
Primary	Time to progression (TTP)	the time from randomization until cancer progression, not including death.	2 years
Secondary	Overall survival (OS)	The length of time that the patients are still alive at a defined period of time after treatment	2 years
Secondary	Patient quality of life	Quality of patients enrolling in the study assessed using EORTC-CR29 questionnaire	each 3 months for 2 years