Autologous Killer Cell Therapy in Colon Cancer Patients

Phase 1

• Conditions: Colon Cancer Stage IV
• Interventions: Biological: Cytokine-induced killer cell; Other: Chemotherapy AND/OR Radiation Therapy

• Registration Number: NCT03329664
• Lead Sponsor: Sabz Biomedicals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-30
• Study First Submitted QC: 2017-10-30
• Study First Posted: 2017-11-06
• Study Start: 2020-02-09
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-11
• Last Update Posted: 2021-03-15
• Primary Completion: 2021-09
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CIK Intervention plus routine treatment	Chemotherapy AND/OR Radiation Therapy	Patients who receive their routine treatment (chemotherapy, radiation therapy) + Cytokine-induced killer cell infusion
Control	Chemotherapy AND/OR Radiation Therapy	Patients who receive routine treatments only (chemotherapy, radiation therapy)
CIK Intervention plus routine treatment	Cytokine-induced killer cell	Patients who receive their routine treatment (chemotherapy, radiation therapy) + Cytokine-induced killer cell infusion

Primary Outcome Measures

Name	Time	Method
Time to progression (TTP)	2 years	the time from randomization until cancer progression, not including death.
Progression-free Survival (PFS)	2 years	The time from treatment initiation day to first documented progressive disease or death due to disease.
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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Gene Therapy Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences; 🇮🇷 Tehran, Iran, Islamic Republic of