Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma
ConditionHepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age20-60
SponsorDr Cipto Mangunkusumo General Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Autologous Natural Killer Cell Therapy
DrugThe therapy will be administered intravenously
Clinimacs Plus
DeviceThe 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.
Treatment groups
3 Participants
are divided into 1 treatment groupGroup A: Autologous Natural Killer CellExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 months2
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 months3
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 months4
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 yearsSponsors and contacts
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Source ClinicalTrials.gov