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New treatment option for Ovarian Neoplasms Malignant
Official title Intraperitoneal SK-NK Cell Injection for Advanced Ovarian Cancer With Massive Ascites
ClinicalTrials.gov ID: NCT07435701
What this study is testing
What is SK-NK Cell Injection?
SK-NK Cell Injection is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for ovarian neoplasms malignant.
Also referred to as Super Kill-NK Cell Injection, Allogeneic NK Cell Injection.
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
- This is a single-center, open-label, Phase I/II clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of SK-NK Cell Injection administered via intraperitoneal (IP) perfusion in patients with advanced ovarian cancer complicated by massive ascites . The study focuses on patients who have failed standard therapies and are suffering from severe ascites.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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...
- 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:
You likely can't join if
- Prior receipt of other cell therapies. Presence of loculated (septated) ascites indicated by CT or Ultrasound. Receipt of any systemic anti-tumor...
- 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...
- 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.
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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).
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 female, 18 years and older. 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.