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NCT Number: NCT06044506

Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cipto Mangunkusumo General Hospital

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location status: Recruiting

Location contact

Ardhi Rahman Ahani, MD

CONTACT

+62 87870171876

Ardhi Rahman Ahani, MD

SUB_INVESTIGATOR

Chyntia Olivia Maurine Jasirwan, MD, PhD

SUB_INVESTIGATOR

Cosphiadi Irawan, MD, PhD

CONTACT

Cosphiadi Irawan, MD, PhD

PRINCIPAL_INVESTIGATOR

Iqbal Fasha, MBiomed

SUB_INVESTIGATOR

Isabella Kurnia Liem, MD, MBiomed, PhD

SUB_INVESTIGATOR

Radiana Dhewayani Antarianto, MD, MBiomed, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous Natural Killer Cell Therapy

Drug

The therapy will be administered intravenously

Clinimacs Plus

Device

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.

Primary outcomes

  1. Optimal treatment dosage

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

    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.

Secondary outcomes

  1. Tumor Shrinkage

    Time frame: Up to 6 months

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

  2. Immunological Responses

    Time frame: Up to 6 months

    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.

  3. Hematology Profile

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

    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

  4. Progression-free survival

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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Ardhi Rahman Ahani, MD

CONTACT

[email protected]

+62 87870171876

Firshan Makbul, MD

CONTACT

[email protected]

+62 81242625535

Sponsors and collaborators

Lead sponsor

Dr Cipto Mangunkusumo General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Sep 21, 2023
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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