NCT06044506

Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (estimated)
• Sponsor: Dr Cipto Mangunkusumo General Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-29
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2023-09-21
• Last updated: 2023-09-26

Locations

1 site across 1 country: Indonesia

Regulatory

• FDA-regulated device study