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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatocellular Carcinoma | Drug: Autologous Natural Killer Cell Therapy Device: Clinimacs Plus | Phase 1 |
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 |
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. |
- 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.
- 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.
- 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.
- 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
- 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
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Ages Eligible for Study: | 20 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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
Contact: Ardhi Rahman Ahani, MD | +62 87870171876 | ardhi.ahani@gmail.com | |
Contact: Firshan Makbul, MD | +62 81242625535 | makbulfirshan@gmail.com |
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 |
Principal Investigator: | Cosphiadi Irawan, MD, PhD | Cipto Mangunkusumo Hospital/Faculty of Medicine, Universitas Indonesia |
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 |
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 |
Natural Killer Cell Immunotherapy Hepatocellular Carcinoma |
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 |