Immune cell therapy targets belly fluid in ovarian cancer
NCT ID NCT07435701
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new treatment for advanced ovarian cancer patients who have a lot of fluid in their belly (ascites) and have not responded to standard therapies. The treatment involves injecting special immune cells called SK-NK cells directly into the abdomen once a week for four weeks. The goal is to see if it is safe and can reduce the need for fluid drainage. The trial is small, with 29 participants, and is in early phases to find the right dose and check for side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SK-NK cells (a type of immune cell from a donor, given into the belly)
- What this could lead to
- If it works, this could offer a new way to control severe fluid buildup and slow tumor growth in advanced ovarian cancer patients who have run out of standard options.
- What could go wrong
- This is a very early, small trial (29 people) testing safety and dosing first. It may not work, and there are risks like allergic reactions or side effects from the cell infusion.
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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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 29 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 years and older
- Sex
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Female participants only
- 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: Voluntarily sign the written Informed Consent Form (ICF) and be able to comply with study procedures and follow-up. Female, aged 18 to 75 years. ECOG performance status of 0 to 2. Histologically or cytologically confirmed advanced ovarian cancer. Participants must have failed at least two lines of standard therapy (disease progression or intolerance), have no standard therapy available, or be unable to receive standard therapy for other reasons . Complicated by massive malignant ascites, defined as a volume of ≥ 2000 mL indicated by Ultrasound or CT. Expected survival time ≥ 3 months. Adequate organ function (no blood transfusion, cell growth factors, etc., within 14 days prior to enrollment), defined as: Neutrophils (ANC) ≥ 1.0×10\^9/L Platelets (PLT) ≥ 80×10\^9/L Hemoglobin (Hb) ≥ 80 g/L Total Bilirubin (TBIL) ≤ 1.5×ULN (≤ 3×ULN for Gilbert's syndrome or liver metastasis) ALT and AST ≤ 2.5×ULN (≤ 5×ULN if liver metastasis is present) INR ≤ 1.5×ULN and APTT ≤ 1.5×ULN (unless on anticoagulant therapy) Creatinine clearance ≥ 60 mL/min (calculated by Cockcroft-Gault formula) Toxicities from prior therapies must have recovered to ≤ Grade 1 (except for alopecia and ≤ Grade 2 neurotoxicity caused by chemotherapy) . Exclusion Criteria: Prior receipt of other cell therapies. Presence of loculated (septated) ascites indicated by CT or Ultrasound. Receipt of any systemic anti-tumor therapy (including chemotherapy, targeted therapy, etc.) within 3 weeks prior to intraperitoneal perfusion. Receipt of Traditional Chinese Medicine (herbal) with anti-tumor indications within 3 weeks prior to intraperitoneal perfusion. Receipt of systemic corticosteroids (≥ 10 mg/day prednisone or equivalent) or other immunosuppressive medications within 2 weeks prior to intraperitoneal perfusion (inhaled, topical, or physiologic replacement doses are allowed). Major surgery within 4 weeks prior to screening or planned major surgery during the study period. History of other malignancies within 5 years (except for cured local tumors with low risk of recurrence, such as non-melanoma skin cancer). History of active or suspected autoimmune or inflammatory disease. History of organ transplantation or hematopoietic stem cell transplantation. Presence of active infection, including: Active Hepatitis B (HBsAg positive and HBV-DNA \> 1000 copies/mL) Active Hepatitis C (HCV antibody positive and HCV-RNA detected) Systemic active infection requiring antibiotic treatment Congenital or acquired immunodeficiency (e.g., HIV infection) Vaccination with live or attenuated vaccines within 4 weeks prior to intraperitoneal perfusion. Severe cardiovascular diseases, including: Uncontrolled hypertension (SBP \> 160 mmHg and/or DBP \> 100 mmHg) History of hypertensive crisis or hypertensive encephalopathy Cardiovascular accident, TIA, myocardial infarction, unstable angina, or significant vascular disease within 6 months NYHA Class ≥ II heart failure or LVEF \< 50% Severe arrhythmia uncontrolled by medication (QTc ≥ 450 ms for males, ≥ 470 ms for females), or congenital Long QT syndrome Severe respiratory disease (e.g., history of severe interstitial lung disease, severe COPD), FEV1 \< 2L, or DLCO \< 40%. History of clear neurological or psychiatric disorders, including epilepsy or dementia. Other conditions considered unsuitable for the study by the investigator (e.g., prior Grade ≥ 3 adverse events from immunotherapy).
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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
Show contact details
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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, 100021, China
Contact Email: •••••@•••••
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