Hepatocellular CarcinomaPhase 1NCT06044506
Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma
A Phase 1 study testing Autologous Natural Killer Cell Therapy and Clinimacs Plus in people with Hepatocellular Carcinoma, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Autologous Natural Killer Cell Therapy and Clinimacs Plus
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteIndonesia
- Study dates
- 29 Aug 2022to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site, 1 recruiting
- Recruiting
Cipto Mangunkusumo General Hospital
Jakarta Pusat, Jakarta Special Capital Region, 10430
Ardhi Rahman Ahani, MD, +62 87870171876
Cosphiadi Irawan, MD, PhD
About this study
Official title: A Phase I Study of 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Autologous Natural Killer Cell Therapy, Clinimacs Plus
- Keywords
- Natural Killer Cell, Immunotherapy, Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Natural Killer Cell TherapyDrug
The therapy will be administered intravenously
Clinimacs PlusDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Autologous Natural Killer Cell | Experimental | 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. Receives: Drug: Autologous Natural Killer Cell Therapy; Device: Clinimacs Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Start of infusion of Autologous NK cells (Day 0) until up to 6 months
Secondary outcomes (4)
Tumor Shrinkage
CT scans will measure tumor size at baseline and specific post-infusion times. Tumor response will be assessed using mRECIST criteria.
Measured: Up to 6 months
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.
Measured: Up to 6 months
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
Measured: Start of infusion of Autologous NK cells (Day 0) until up to 6 months
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
Measured: Start of infusion of Autologous NK cells (Day 0) until progressive disease or death, whichever comes first, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start29 Aug 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Cipto Mangunkusumo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cosphiadi Irawan, Dr Cipto Mangunkusumo General Hospital
- Investigators
- Cosphiadi Irawan, MD, PhD, Principal investigator, Cipto Mangunkusumo Hospital/Faculty of Medicine, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044506
- Sponsor's protocol ID
- 22080996
- Status last verified
- Sep 2023
- First submitted
- 1 Sep 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06044506
- Acronym / sponsor ID
- 22080996
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Natural Killer Cell, Immunotherapy, Hepatocellular Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Dr Cipto Mangunkusumo General HospitalUniversity, hospital or other
- Study start
- 29 Aug 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous Natural Killer Cell | Experimental | Drug: Autologous Natural Killer Cell Therapy, Device: Clinimacs PlusDosage 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Natural Killer Cell TherapyThe therapy will be administered intravenously | Drug | Autologous Natural Killer Cell |
| Clinimacs PlusThe 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. | Device | Autologous Natural Killer Cell |
Primary outcome
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.
4 secondary outcomes
Tumor Shrinkage
Time frame: Up to 6 months
Immunological Responses
Time frame: Up to 6 months
Hematology Profile
Time frame: Start of infusion of Autologous NK cells (Day 0) until up to 6 months
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cosphiadi Irawan, MD, PhD principal investigator
Cipto Mangunkusumo Hospital/Faculty of Medicine, Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous Natural Killer Cell Therapy and Clinimacs Plus in people with Hepatocellular Carcinoma, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ardhi Rahman Ahani, MD (+62 87870171876, ardhi.ahani@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal treatment dosage (time frame: Start of infusion of Autologous NK cells (Day 0) until up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.