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New treatment option for Advanced Solid Tumors
Official title NK521 in the Treatment of Malignant Ascites Associated With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07561437
What this study is testing
What is NK521 Cell Injection?
NK521 Cell Injection is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for advanced solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Study Population: Adult subjects aged 18-75 years with relapsed/refractory advanced solid tumors (including liver, gastric, colorectal, ovarian cancer, etc.) and malignant ascites confirmed by cytology, who have failed at least 2 lines of standard systemic therapy. Study Design: This is a dose-escalation, single-center, open-label, prospective Phase 1 study.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Pathologically diagnosed with relapsed/refractory advanced solid tumors, including but not limited to liver cancer, gastric cancer, colorectal...
- Complicated with malignant ascites with identifiable tumor cells in ascites. Patients with advanced solid tumors who have failed at least 2 lines of...
- At least one measurable lesion on CT or MRI per RECIST v1.1.
- ECOG performance status 0-2.
- Life expectancy ≥3 months.
You likely can't join if
- 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...
- 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...
- Received radical radiotherapy within 4 weeks before enrollment; received local palliative radiotherapy within 2 weeks before enrollment. Not fully...
See the full eligibility 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; people with long-term stable sequelae from prior therapy (e.g., platinum-induced...
- Women of childbearing potential must be non-lactating with a negative serum pregnancy test within 1 week before enrollment; all people must agree to use contraception from signing informed consent until 6 months after...
- Able to comply with the study protocol and follow-up procedures.
- Voluntarily signed and provided written informed consent.
- 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...
- 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...
- 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...
- 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...
- Positive virology test for hepatitis B or hepatitis C at screening, meeting any of the following:
- HBsAg positive with positive HBV-DNA titer or above upper limit of normal (ULN);
- HCV antibody positive.
- Known hypersensitivity or intolerance to PD-1 monoclonal antibody. Meeting any of the following laboratory criteria:
- Hematology: Absolute neutrophil count \<1.5×10⁹/L; platelet count \<75×10⁹/L; hemoglobin \<90 g/L.
- 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 people with Gilbert syndrome.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.