Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma

Phase 1RecruitingNCT06044506

Dr Cipto Mangunkusumo General Hospital3 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatocellular Carcinoma

Interventions

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Start of infusion of Autologous NK cells (Day 0) until up to 6 months

Secondary Outcomes

Tumor Shrinkage

CT scans will measure tumor size at baseline and specific post-infusion times. Tumor response will be assessed using mRECIST criteria.

Time frame: Up to 6 months

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.

Time frame: Up to 6 months

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

Time frame: Start of infusion of Autologous NK cells (Day 0) until up to 6 months

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

Time frame: Start of infusion of Autologous NK cells (Day 0) until progressive disease or death, whichever comes first, up to 2 years