RecruitingPhase 1NCT06044506

Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma

A Phase I Study of Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma


Sponsor

Dr Cipto Mangunkusumo General Hospital

Enrollment

3 participants

Start Date

Aug 29, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This study represents a phase I clinical trial that utilizes natural killer (NK) cell therapy for patients diagnosed with liver cancer, specifically those classified as Child-Pugh A and falling within the Barcelona Clinic Liver Cancer (BCLC) stages B or C. The expected results include determining the suitable treatment dosage, identifying any resulting side effects, and calculating the average duration of progression-free survival. The target group for the study consists of all individuals diagnosed with liver cancer. At the same time, the practical sample consists of those who received medical care for liver cancer at Cipto Mangunkusumo Hospital (RSCM) between May and December 2022. The chosen research sample comprises liver cancer patients who fulfill the predetermined participation criteria. The necessary sample size for discerning appropriate treatment dosages and the occurrence rate of potential side effects shall consist of 2-3 liver cancer patients who are administered autologous NK cells. The process for isolating these NK cells adheres to the guidelines established by Miltenyi Biotec.


Eligibility

Min Age: 20 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether using a patient's own natural killer (NK) cells — a type of immune cell — as a therapy can safely and effectively treat liver cancer (hepatocellular carcinoma). The cells are collected from the patient, expanded in a lab, and then given back to fight the tumor. **You may be eligible if...** - You are 18 or older - You have been diagnosed with hepatocellular carcinoma (liver cancer) - Your cancer has not responded to or is not suitable for standard treatments - Your liver function and overall health meet the study thresholds **You may NOT be eligible if...** - You have severe liver failure or uncontrolled infections - You have active autoimmune diseases - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAutologous Natural Killer Cell Therapy

The therapy will be administered intravenously

DEVICEClinimacs Plus

The CliniMACS Plus device is an automated cell separation tool that uses MACS Technology. It incorporates a flexible system designed for isolating clinically labeled cells using MicroBeads.


Locations(1)

Cipto Mangunkusumo General Hospital

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06044506


Related Trials