Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06044506
• Other study ID #: 22080996
• Status: Recruiting
• Phase: Phase 1
• Start date: August 29, 2022
• Est. completion date: December 2026

Study information

• Verified date: September 2023
• Source: Dr Cipto Mangunkusumo General Hospital
• Contact: Ardhi Rahman Ahani, MD
• Phone: +62 87870171876
• Email: ardhi.ahani[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients aged 20-60 years old
• Patients with Hepatocellular Carcinoma (HCC) staged as BCLC B and C
• Karnofsky Performance Status (KPS) score = 70
• Expected patient survival of more than three months
• The following parameters are within the normal range:

Platelet count = 80,000/µL White blood cell count = 3000/µL Neutrophil count = 2000 Hemoglobin = 9 mg/dL International Normalized Ratio (INR) 0.8-1.5 Adequate liver function (bilirubin < 2, SGOT and SGPT < 60 U/L) Adequate kidney function (serum creatinine < 1.3, serum urea < 10)

Exclusion Criteria:

• Refusing to participate in the study
• Afflicted by other malignancies, whether non-HCC liver or other malignancies
• Patients are affected by other conditions such as hypertension, severe coronary disease, myelosuppression, respiratory disorders, and acute or chronic infections
• Patients who have previously undergone transplantation and received other stem cell therapies

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

Country	Name	City	State
Indonesia	Cipto Mangunkusumo General Hospital	Jakarta Pusat	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Dr Cipto Mangunkusumo General Hospital

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optimal treatment dosage	To evaluate the safety of autologous NK cell infusion and discover dose-limiting toxicities (DLT). This evaluation will determine the recommended dosage for the next trial phase.	Start of infusion of Autologous NK cells (Day 0) until up to 6 months
Secondary	Tumor Shrinkage	CT scans will measure tumor size at baseline and specific post-infusion times. Tumor response will be assessed using mRECIST criteria.	Up to 6 months
Secondary	Immunological Responses	Flow cytometry will evaluate infused NK cells' biomarkers, such as CD45 and CD56, that persist in peripheral blood. These biomarkers will be evaluated pre- and post-infusion.	Up to 6 months
Secondary	Hematology Profile	Changes of Complete Blood Count (CBC), Differential Blood Count, Coagulation Profile, Mean Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amio Transferase (AST) from baseline at each assessment time point	Start of infusion of Autologous NK cells (Day 0) until up to 6 months
Secondary	Progression-free survival	This metric indicates the period during which a patient's condition shows no signs of progressing or deteriorating subsequent to the administration of autologous natural killer (NK) cell therapy	Start of infusion of Autologous NK cells (Day 0) until progressive disease or death, whichever comes first, up to 2 years