Engineered immune cells take on Cancer-Related fluid swelling
NCT ID NCT07561437
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial is testing a new treatment called NK521 for people with advanced solid tumors that have spread and caused fluid buildup in the belly (malignant ascites). The treatment uses a person's own natural killer (NK) cells that have been gene-edited to better attack cancer. The study will enroll 18 adults who have tried at least two standard treatments without success. The main goal is to check safety, but researchers will also look for signs that the treatment controls the cancer or reduces the need for fluid drainage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Gene-edited natural killer (NK) cells
- What this could lead to
- If successful, this could point toward a new way to control malignant ascites and improve quality of life in people with advanced solid tumors.
- What could go wrong
- This is a very early, small Phase 1 trial with only 18 participants, so it is primarily testing safety. The treatment may not shrink tumors or control ascites, and side effects are unknown.
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
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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: * Pathologically diagnosed with relapsed/refractory advanced solid tumors, including but not limited to liver cancer, gastric cancer, colorectal cancer, ovarian cancer, etc. * Complicated with malignant ascites with identifiable tumor cells in ascites. Patients with advanced solid tumors who have failed at least 2 lines 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. * All toxicities from prior antineoplastic therapy have resolved to Grade 1 (CTCAE v5.0) or baseline except alopecia and fatigue; subjects with long-term stable sequelae from prior therapy (e.g., platinum-induced neuropathy) are allowed. * 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 other malignancies within the past 3 years. * Active, known or suspected autoimmune disease, excluding hypothyroidism requiring only hormone replacement therapy, skin diseases not requiring systemic therapy (e.g., vitiligo, psoriasis, alopecia), or diseases not expected to relapse without external triggers. * 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. Not fully recovered from major surgery or trauma within 2 weeks before enrollment. -Participated in another investigational drug trial and received investigational therapy or used an investigational device within 4 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: 1. HBsAg positive with positive HBV-DNA titer or above upper limit of normal (ULN); 2. HCV antibody positive. * Known hypersensitivity or intolerance to PD-1 monoclonal antibody. Meeting any of the following laboratory criteria: 1. Hematology: Absolute neutrophil count \<1.5×10⁹/L; platelet count \<75×10⁹/L; hemoglobin \<90 g/L. 2. 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. 3. Renal function: Serum creatinine \>1.5×ULN or creatinine clearance \<50 mL/min. * Any uncertain factors affecting subject safety or compliance. * 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.
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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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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Cancer Hospital, Chinese Academy of Medical Sciences
RECRUITINGBeijing, Beijing Municipality, 010, China
Contact Email: •••••@•••••
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