Actively Recruiting
Intraperitoneal SK-NK Cell Injection for Advanced Ovarian Cancer With Massive Ascites
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2026-03-17
29
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
Sponsors
C
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead Sponsor
C
Cells First Biotechnology (Beijing) Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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. The treatment involves the direct infusion of allogeneic, highly activated Natural Killer (NK) cells (SK-NK) into the abdominal cavity . The study consists of two phases: Phase I (Dose Escalation): To determine the safety profile and the Recommended Phase 2 Dose (RP2D) using a "3+3" design with three increasing dose levels. Phase II (Dose Expansion): To further evaluate the efficacy of the treatment in controlling ascites and suppressing tumor growth at the determined RP2D. Participants will receive the study treatment once weekly for 4 weeks.
CONDITIONS
Official Title
Intraperitoneal SK-NK Cell Injection for Advanced Ovarian Cancer With Massive Ascites
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 75 years
- Signed informed consent and able to comply with study procedures
- ECOG performance status of 0 to 2
- Histologically or cytologically confirmed advanced ovarian cancer
- Failed at least two lines of standard therapy or no standard therapy available or unable to receive standard therapy
- Complicated by massive malignant ascites with volume 2000 mL confirmed by Ultrasound or CT
- Expected survival time of at least 3 months
- Adequate organ function including neutrophils 1.0 x 10^9/L, platelets 80 x 10^9/L, hemoglobin 80 g/L
- Total bilirubin 1.5 x upper limit of normal (ULN) (or 3 x ULN for Gilbert's syndrome or liver metastasis)
- ALT and AST 2.5 x ULN (or 5 x ULN if liver metastasis present)
- INR and APTT 1.5 x ULN unless on anticoagulant therapy
- Creatinine clearance 60 mL/min (Cockcroft-Gault formula)
- Toxicities from prior therapies recovered to Grade 1 or below except alopecia and chemotherapy-related neurotoxicity Grade 2 or below
You will not qualify if you...
- Prior receipt of other cell therapies
- Presence of loculated (septated) ascites
- Any systemic anti-tumor therapy within 3 weeks prior to intraperitoneal perfusion
- Use of Traditional Chinese Medicine with anti-tumor effects within 3 weeks prior to perfusion
- Use of systemic corticosteroids ( 10 mg/day prednisone or equivalent) or immunosuppressants within 2 weeks prior to perfusion (except inhaled, topical, or physiologic replacement doses)
- Major surgery within 4 weeks prior to screening or planned during study
- History of other malignancies within 5 years except cured low-risk local tumors
- History of active or suspected autoimmune or inflammatory disease
- History of organ or stem cell transplantation
- Active infections including Hepatitis B or C, systemic infection requiring antibiotics, immunodeficiency (e.g., HIV)
- Vaccination with live or attenuated vaccines within 4 weeks prior to perfusion
- Severe cardiovascular diseases including uncontrolled hypertension, recent cardiovascular events, heart failure NYHA Class II or above, low left ventricular ejection fraction, severe arrhythmia
- Severe respiratory diseases such as severe interstitial lung disease, severe COPD, FEV1 < 2L, or DLCO < 40%
- History of neurological or psychiatric disorders including epilepsy or dementia
- Any other conditions deemed unsuitable by the investigator including prior Grade 3 or higher immunotherapy adverse events
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
N
Ning Li, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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