Clinical trial NCT06044506: Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma
Official title: A Phase I Study of Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hepatocellular Carcinoma
Keywords: Natural Killer Cell
Immunotherapy
Hepatocellular Carcinoma
Lead sponsor: Dr Cipto Mangunkusumo General Hospital
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 3
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Optimal treatment dosage
timeFrame: Start of infusion of Autologous NK cells (Day 0) until up to 6 months
Secondary outcomes:
measure: Tumor Shrinkage
timeFrame: Up to 6 months
measure: Immunological Responses
timeFrame: Up to 6 months
measure: Hematology Profile
timeFrame: Start of infusion of Autologous NK cells (Day 0) until up to 6 months
measure: Progression-free survival
timeFrame: Start of infusion of Autologous NK cells (Day 0) until progressive disease or death, whichever comes first, up to 2 years
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo General Hospital
state: Jakarta
Study officials:
affiliation: Cipto Mangunkusumo Hospital/Faculty of Medicine, Universitas Indonesia
name: Cosphiadi Irawan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: