Can immune cells from belly fluid fight advanced cancer?
NCT ID NCT07378436
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests a new treatment called GK02 for people with advanced solid tumors that cause fluid buildup in the belly (malignant ascites). The treatment uses the patient's own immune cells taken from that fluid, grown in a lab, and then given back. Only 9 participants will be enrolled to check safety and see if it helps control the fluid or the cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tumor-reactive T cells (GK02) taken from the patient's own ascites fluid
- What this could lead to
- If it works, this could point toward a new way to control malignant ascites and slow tumor growth in advanced cancers.
- What could go wrong
- This is a very early, tiny trial (9 people) focused on safety. The treatment may not shrink tumors or improve survival, and side effects could be serious.
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 9 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Dec 2027
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: 1. Ability to understand and sign a written informed consent document; 2. At the date of signing ICF, 18 \~75 years old, male or female; 3. Patients with advanced solid tumors confirmed by histology or pathology to have failed at least second-line treatment (treatment failure is defined as progression after treatment or intolerance after treatment), including but not limited to gastric cancer, colorectal cancer, pancreatic cancer, ovarian cancer, etc.; 4. Pathological diagnosis or clinical diagnosis of malignant ascites, and the researcher determines that treatment for malignant ascites is necessary; During screening, the ascites volume was confirmed to be above the medium level by ultrasound (the maximum depth of ascites in the supine position was ≥3.0cm, and the total volume was ≥500ml); 5. ECOG 0-2 points; 6. Adequate organ functions; 7. There are no absolute or relative contraindications for puncture; 8. No peritoneal treatment for malignant ascites has been carried out within 14 days prior to the collection of malignant ascites; 9. Female of childbearing age who have a negative urine pregnancy test during the screening period and agree to take effective contraceptive measures for at least 6 months after perfusion; Male subjects whose partners are fertile must agree to use effective contraceptive methods and avoid sperm donation for at least six months after perfusion. Exclusion Criteria: 1. Those with a history of severe allergies or allergic reactions to any components of the drugs to be used in this study, including but not limited to NMA-LD drugs, contrast agents and contrast agents used in imaging examinations, excipients such as dimethyl sulfoxide (DMSO) and antibiotics in cell products; 2. Central nervous system (CNS) metastasis is present; 3. Toxicity from previous antitumor therapy did not return to grade 1 or baseline levels (CTCAE version 5.0); 4. Accompanied or prior to interstitial lung disease or interstitial pneumonia; 5. Uncontrolled metabolic disorders, such as those in patients with diabetes (glycated hemoglobin ≥8.5%), or secondary reactions to other non-malignant organ or systemic diseases or cancer, which can lead to higher medical risks and/or uncertainties in survival assessment; 6. An autoimmune disease that is active or has previously suffered from and is likely to recur; 7. Uncontrolled comorbidities include but are not limited to uncontrolled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg) or any unstable cardiovascular and cerebrovascular diseases that occurred within 6 months prior to treatment enrollment; 8. Ultrasound indicates the separation of peritoneal effusion; 9. Patients with intestinal obstruction; 10. Patients with comorbidities or active autoimmune diseases that require the use of glucocorticoids or other immunosuppressive drugs during the trial period, excluding local transdermal absorption of glucocorticoids (i.e., no more than 5mg/ day of prednisone or equivalent doses of other glucocorticoids); 11. Women who are pregnant or breastfeeding.
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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 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
Locations
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Beijing GoBroad Hospital
RECRUITINGBeijing, China