Autologous Natural Killer Cell Therapy for Hepatocellular Carcinoma
NCT ID: NCT06044506
Last Updated: 2023-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
3 participants
INTERVENTIONAL
2022-08-29
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Autologous Immune Killer Cells to Treat Liver Cancer Patients as an Adjunct Therapy
NCT03592706
Hepatic Artery Transfusion of NKG2D CAR-NK Cells Followed by Intravenous Infusion of NKG2D CAR-T Cells to Treat Patients With Advanced Solid Tumors With Liver Metastases Who Have Failed Standard Treatments: a Phase I Exploratory Clinical Trial
NCT07021534
A Phase I, Open-label Study to Assess the Safety and Efficacy of Poly-ICLC Plus Nivolumab in Unresectable Hepatocellular Carcinoma Patients
NCT05281926
A Study to Evaluate Autologous CIK Cells in Patients With Hepatocellular Carcinoma After TACE, PEIT or RFA
NCT03124498
By Using Adoptive Transfer of Autologous NK Cells to Prevent Recurrence of Hepatocellular Carcinoma After Curative Therapy
NCT02725996
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Autologous Natural Killer Cell Therapy
The therapy will be administered intravenously
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Autologous Natural Killer Cell Therapy
The therapy will be administered intravenously
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
20 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dr Cipto Mangunkusumo General Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Cosphiadi Irawan
Head of Hematology-Medical Oncology Division, Dr Cipto Mangunkusumo General Hospital
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Cosphiadi Irawan, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Cipto Mangunkusumo Hospital/Faculty of Medicine, Universitas Indonesia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cipto Mangunkusumo General Hospital
Jakarta Pusat, Jakarta Special Capital Region, Indonesia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Ardhi Rahman Ahani, MD
Role: primary
Cosphiadi Irawan, MD, PhD
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
22080996
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.