An Early Phase 1 interventional study of Autologous Cytokine-Induced Killer (CIK) Cells in Hepatocellular Carcinoma (HCC), sponsored by Royan Institute. Not yet recruiting at 1 site in Iran. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Royan Institute · Early Phase 1, Interventional, and Treatment
This study tests whether it is safe and feasible to give patients with hepatocellular carcinoma (liver cancer) an infusion of their own (autologous) immune cells, called cytokine-induced killer (CIK) cells, after they have had surgery to remove their liver tumor. The patient's own blood cells are collected and grown in a laboratory to create the CIK cells, which are then given back to the patient through six intravenous infusions over about two months. Patients are followed for six months to check for side effects and early signs of whether the cancer returns.
Hepatocellular carcinoma (HCC) is the most common primary liver malignancy and a leading cause of cancer-related mortality worldwide. Even after curative-intent surgical resection, disease recurrence occurs in approximately 60-70% of patients within five years, and no adjuvant systemic therapy has demonstrated a consistent recurrence-free survival or overall survival benefit in this setting. Cytokine-induced killer (CIK) cells are ex vivo-expanded autologous immune effector cells with a heterogeneous phenotype dominated by CD3⁺CD56⁺ cells, combining T-cell and NK-cell features and exhibiting MHC-unrestricted cytotoxicity against tumor cells. Phase II/III trials and subsequent meta-analyses conducted predominantly in East Asian populations have reported improved recurrence-free and overall survival with adjuvant CIK therapy following HCC resection, without a corresponding increase in severe (Grade ≥3) adverse events, and the South Korean Ministry of Food and Drug Safety approved a CIK-based product (Immuncell-LC) on this basis in 2022. No clinical data exist to date for an Iranian population, which differs from East Asian cohorts in HCC etiology (notably HBV prevalence and metabolic-associated steatotic liver disease burden) and genetic background.
This is a single-center, open-label, single-arm, phase I safety and feasibility study conducted at the Liver Transplant and Surgery Research Center, Imam Khomeini Hospital, Tehran University of Medical Sciences, in collaboration with Royan Institute. Full eligibility criteria are listed in the Eligibility section of this record.
For each patient, peripheral blood mononuclear cells (PBMCs) are isolated and expanded ex vivo under Good Manufacturing Practice (GMP) conditions for 14-21 days using IFN-γ, anti-CD3 antibody, and IL-2 to generate the autologous CIK cell product. Prior to release, each batch undergoes quality control testing for viability, CD3⁺CD56⁺ phenotype, antitumor cytotoxicity, sterility, and endotoxin level against pre-specified thresholds (≥85% viability, ≥60% CD3⁺CD56⁺, ≥30% cytotoxicity, endotoxin ≤5 EU/kg, negative microbial/mycoplasma testing); only batches meeting these criteria are released for infusion.
Each patient receives six intravenous infusions of autologous CIK cells administered as a slow infusion over approximately 60 minutes under sterile conditions: three weekly infusions (weeks 0, 1, and 2) followed by three biweekly infusions (weeks 4, 6, and 8). Vital signs are monitored before, during, and for two hours after each infusion. No routine premedication is given; mild fever is managed with acetaminophen. Adverse event monitoring and grading methodology are detailed under Outcome Measures. Over the 6-month follow-up period, scheduled assessments also include laboratory testing (including AFP, PIVKA-II, liver function and coagulation panels), peripheral blood lymphocyte immunophenotyping (CD56⁺CD16⁺CD3-, CD3⁺CD8⁺, CD3⁺CD56⁺CD16⁺, CD3⁺CD4⁺ populations at month 6 versus baseline), and contrast-enhanced MRI at months 3 and 6. Given the phase I descriptive design and small sample size, statistical analysis is planned to be descriptive rather than inferential.
3,648 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,061 are open to participants now.
This study's planned enrollment of 6 is below the median of 54 across 2,618 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Royan Institute is the lead sponsor of 94 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with HCC who have undergone curative surgical resection receive six intravenous infusions of autologous CIK cells (three weekly, three biweekly) in addition to standard postoperative care.
Biological: Autologous Cytokine-Induced Killer (CIK) Cells
PBMCs are collected from the patient, expanded ex vivo for 14-21 days under GMP conditions administered as 6 intravenous infusions (weeks 0, 1, 2, then weeks 4, 6, 8) following release testing for sterility, viability, and phenotype.
Incidence and severity of adverse events following CIK cell infusion
Frequency, type, severity, and relatedness of adverse events (AEs) and serious adverse events (SAEs), graded per CTCAE v5.0.
Time frame: From first infusion through 6 months post-treatment (assessed at weeks 1-10 and months 3 and 6)
Recurrence-Free Survival (RFS)
Time from study enrollment to first tumor recurrence (intrahepatic or extrahepatic) or death from any cause, whichever occurs first.
Time frame: From date of enrollment until first documented intrahepatic or extrahepatic tumor recurrence, or death from any cause, whichever occurs first, assessed up to 6 months
Overall Survival (OS)
Time from study enrollment to death from any cause.
Time frame: From date of enrollment until death from any cause, assessed up to 6 months
Plan to share: Undecided
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Studies of the drug tested here: Autologous Cytokine-induced Killer Cells
Royan Institute