Actively Recruiting
NK521 in the Treatment of Malignant Ascites Associated With Advanced Solid Tumors
Led by Base Therapeutics (Shanghai) Co., Ltd. · Updated on 2026-05-01
18
Participants Needed
1
Research Sites
133 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. A total of 18 subjects will be enrolled and assigned to 2 administration groups (9 subjects each): Group A (Intravenous infusion): For subjects with small-volume malignant ascites. Group B (Intraperitoneal perfusion): For subjects with large-volume symptomatic malignant ascites. Each group will follow a conventional "3+3" dose-escalation design with 3 dose levels (1×10⁹, 3×10⁹, 6×10⁹ NK cells per dose), administered once weekly, 3 weeks per cycle, for 2 consecutive cycles. Primary Objectives: To evaluate the safety and tolerability, and to determine the dose-limiting toxicity (DLT) of NK521 administered intravenously and intraperitoneally. Secondary Objectives: To assess the preliminary anti-tumor efficacy including objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), puncture-free survival (PuFS), and changes in tumor markers, as well as health-related quality of life (HRQoL).
CONDITIONS
Official Title
NK521 in the Treatment of Malignant Ascites Associated With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Diagnosed with relapsed or refractory advanced solid tumors including liver, gastric, colorectal, ovarian cancer, etc.
- Presence of malignant ascites with identifiable tumor cells confirmed by cytology
- Failed at least two lines of standard systemic therapy
- At least one measurable lesion on CT or MRI per RECIST v1.1 criteria
- ECOG performance status between 0 and 2
- Life expectancy of at least 3 months
- Recovery from prior antineoplastic therapy toxicities to Grade 1 or baseline except alopecia and fatigue
- Women of childbearing potential must be non-lactating with a negative serum pregnancy test within 1 week before enrollment
- Agreement to use contraception from consent signing until 6 months after last NK521 infusion
- Able to follow study protocol and attend follow-up visits
- Voluntarily signed informed consent
You will not qualify if you...
- Symptomatic central nervous system metastasis or carcinomatous meningitis
- History of other malignancies within the past 3 years
- Active or suspected autoimmune diseases except specific exceptions like hypothyroidism requiring hormone replacement or stable skin diseases
- History of immunodeficiency including positive HIV test or organ transplantation
- Severe cardiovascular or cerebrovascular diseases including severe arrhythmias, QTc >480 ms, recent heart events within 6 months, NYHA Class II or higher heart failure, LVEF <50%, or uncontrolled hypertension
- Recent radical radiotherapy within 4 weeks or local palliative radiotherapy within 2 weeks
- Not recovered from major surgery or trauma within 2 weeks
- Participation in other investigational drug trials within 4 weeks
- Received cellular antineoplastic therapy within 1 year or other antineoplastic therapy within 4 weeks
- Received blood transfusions or growth factor therapies within 2 weeks
- Received systemic corticosteroids (>10 mg/day prednisone or equivalent) or immunomodulators within 2 weeks
- Positive hepatitis B or C tests with active infection markers
- Known allergy or intolerance to PD-1 monoclonal antibody
- Laboratory abnormalities including low neutrophil, platelet, or hemoglobin counts; elevated liver enzymes or bilirubin; impaired renal function
- Any other conditions or factors that increase risk or affect study compliance as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here