Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06044506
PHASE1

Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma

Sponsor: Dr Cipto Mangunkusumo General Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

20 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

3

Start Date

2022-08-29

Completion Date

2026-12

Last Updated

2023-09-26

Healthy Volunteers

No

Interventions

DRUG

Autologous Natural Killer Cell Therapy

The therapy will be administered intravenously

DEVICE

Clinimacs 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