Engineered immune cells take on Hard-to-Treat cancers
NCT ID NCT07657416
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests a new cell therapy called NK521 for people with advanced liver cancer (hepatocellular carcinoma) or ovarian cancer that has not responded to standard treatments. NK521 are natural killer (NK) cells that have been gene-edited to remove three proteins that normally slow them down, aiming to make them more effective against tumors. Participants receive the cells either through a vein (for mild fluid buildup) or directly into the abdomen (for moderate to severe fluid buildup, called malignant ascites). The main goal is to check safety, with early signs of tumor shrinkage also being measured.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NK521 Cell Injection (gene-edited natural killer cells)
- What this could lead to
- If successful, this could offer a new treatment option for advanced liver and ovarian cancers, particularly for managing malignant ascites (fluid buildup in the abdomen).
- What could go wrong
- This is a very early, small trial (18 people) focused on safety. The treatment may not shrink tumors or control ascites, and side effects from the cell infusion or gene editing are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Jun 2026
An estimate. Start dates often move.
- Expected to finish
-
Jul 2028
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with pathologically confirmed relapsed/refractory advanced solid tumors, including hepatocellular carcinoma and ovarian cancer. Patients enrolled in the intraperitoneal perfusion group (Group B) must have malignant ascites with tumor cells identified in the ascitic fluid. * Patients with advanced solid tumors who have received ≥ 1 line of standard therapy. * At least one measurable lesion on CT or MRI per RECIST v1.1. * ECOG performance status 0-2. * Life expectancy ≥3 months. * Women of childbearing potential must be non-lactating with a negative serum pregnancy test within 1 week before enrollment; all subjects must agree to use contraception from signing informed consent until 6 months after the last NK521 infusion. * Able to comply with the study protocol and follow-up procedures. * Voluntarily signed and provided written informed consent. Exclusion Criteria: * Symptomatic central nervous system (CNS) metastasis and/or carcinomatous meningitis. * History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency diseases, or organ transplantation. * History of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe cardiac arrhythmia or conduction abnormality requiring clinical intervention (e.g., ventricular arrhythmia, third-degree atrioventricular block); QTc interval \>480 ms on 12-lead ECG at rest; acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade ≥3 cardiovascular/cerebrovascular events within 6 months before enrollment; NYHA Class ≥II heart failure or left ventricular ejection fraction (LVEF) \<50%; uncontrolled hypertension. * Received radical radiotherapy within 4 weeks before enrollment; received local palliative radiotherapy within 2 weeks before enrollment. * Received cellular antineoplastic therapy within 1 year before dosing; received other antineoplastic therapy outside this protocol within 4 weeks before dosing, including but not limited to chemotherapy, molecular targeted therapy, hormonal therapy, immunotherapy, biotherapy, or Chinese herbal patent medicine with antineoplastic indications. * Received blood transfusion, erythropoietin, granulocyte colony-stimulating factor (G-CSF), or granulocyte-macrophage colony-stimulating factor therapy within 2 weeks before enrollment. * Received systemic therapy with corticosteroids (prednisone \>10 mg/day or equivalent) or other immunomodulatory agents (e.g., thymosin, interleukin-2, interferon) within 2 weeks before enrollment. Inhaled or topical corticosteroids are allowed in subjects without active autoimmune disease. * Positive virology test for hepatitis B or hepatitis C at screening, meeting any of the following: a. HBsAg positive with positive HBV-DNA titer or above upper limit of normal (ULN); b. HCV antibody positive. * Meeting any of the following laboratory criteria:a. Hematology: Absolute neutrophil count \<1.5×10⁹/L; platelet count \<75×10⁹/L; hemoglobin \<90 g/L.b. Hepatic function: ALT \>3×ULN (≥5×ULN for liver metastasis); AST \>3×ULN (≥5×ULN for liver metastasis); TBIL \>1.5×ULN, or TBIL \>2.5×ULN (3.0 mg/dL) for subjects with Gilbert syndrome.c. Renal function: Serum creatinine \>1.5×ULN or creatinine clearance \<50 mL/min. * Any other severe or uncontrolled medical disease, active infection, abnormal physical examination, abnormal laboratory test, altered mental status, or psychiatric disease that, in the investigator's opinion, increases subject risk or affects study results.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Hepatocellular carcinoma (HCC) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
1st affiliated hospital of Anhui Medical University
Hefei, Anhui, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Patient's own immune cells fight ovarian cancer?
- Ovarian Cancer's spread: scientists probe abdominal fluid for clues
- New PET tracer aims to light up hidden cancer targets
- Can two immunotherapy drugs make liver tumors more vulnerable to surgery?
- Can inhaled manganese make ovarian cancer immunotherapy hit harder?
- Can a pill shrink Hard-to-Treat ovarian tumors?