Autologous Killer Cell Therapy in Colon Cancer Patients

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03329664

Enrollment

Registered

2017-11-06

Start date

2020-02-09

Completion date

2022-01-31

Last updated

2021-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer Stage IV

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.

Interventions

BIOLOGICALCytokine-induced killer cell

Immune-cell therapy with CIK cells

OTHERChemotherapy AND/OR Radiation Therapy

Routine treatments for colon cancer patients according to their stage

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Iran

Contacts

Primary ContactNaser Ahmadbeigi, Ph.D

n-ahmadbeigi@sina.tums.ac.ir+9821-82415103

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026