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Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma

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ClinicalTrials.gov Identifier: NCT06044506
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : September 26, 2023
Sponsor:
Information provided by (Responsible Party):
Cosphiadi Irawan, Dr Cipto Mangunkusumo General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Autologous Natural Killer Cell Therapy Device: Clinimacs Plus Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma
Actual Study Start Date : August 29, 2022
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2026
Arms and Interventions
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Arm Intervention/treatment
Experimental: Autologous Natural Killer Cell

Dosage Form: Autologous Natural Killer (NK) Cells. These cells will be harvested from the patient's body and infused back into the patient.

Dosage: The specific dose quantity will be determined based on the patient's medical condition and response to the treatment. Customized dosages will be calculated for each individual.

Frequency: The treatment will be given through an intravenous method.

Duration: The length of the treatment will vary depending on how the patient responds and their medical assessment. It may take several weeks to evaluate its effectiveness and potential impacts thoroughly.

 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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06044506


Contacts
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Contact: Ardhi Rahman Ahani, MD +62 87870171876 ardhi.ahani@gmail.com
Contact: Firshan Makbul, MD +62 81242625535 makbulfirshan@gmail.com

Locations
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Indonesia
Cipto Mangunkusumo General Hospital Recruiting
Jakarta Pusat, Jakarta, Indonesia, 10430
Contact: Ardhi Rahman Ahani, MD    +62 87870171876      
Contact: Cosphiadi Irawan, MD, PhD         
Principal Investigator: Cosphiadi Irawan, MD, PhD         
Sub-Investigator: Ardhi Rahman Ahani, MD         
Sub-Investigator: Chyntia Olivia Maurine Jasirwan, MD, PhD         
Sub-Investigator: Radiana Dhewayani Antarianto, MD, MBiomed, PhD         
Sub-Investigator: Isabella Kurnia Liem, MD, MBiomed, PhD         
Sub-Investigator: Iqbal Fasha, MBiomed         
Sponsors and Collaborators
Dr Cipto Mangunkusumo General Hospital
Investigators
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Principal Investigator: Cosphiadi Irawan, MD, PhD Cipto Mangunkusumo Hospital/Faculty of Medicine, Universitas Indonesia
More Information
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Responsible Party: Cosphiadi Irawan, Head of Hematology-Medical Oncology Division, Dr Cipto Mangunkusumo General Hospital, Dr Cipto Mangunkusumo General Hospital
ClinicalTrials.gov Identifier: NCT06044506    
Other Study ID Numbers: 22080996
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 26, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Cosphiadi Irawan, Dr Cipto Mangunkusumo General Hospital:
Natural Killer Cell
Immunotherapy
Hepatocellular Carcinoma
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases