Actively Recruiting
CAR-NK Cells (CL-NK-001) in Pancreatic Cancer
Led by Changhai Hospital · Updated on 2025-06-04
30
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-center, open-label, first-in-human, dose-escalation study in patients with pancreatic cancer.
CONDITIONS
Official Title
CAR-NK Cells (CL-NK-001) in Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18-70 years
- Diagnosed with locally advanced, metastatic, or recurrent pancreatic cancer with eGR1 membrane positive tumor cell rate >40% and expression intensity 62;2+
- Failed, intolerant to, or rejected standard treatment
- At least 1 measurable lesion according to RECIST 1.1
- No anti-tumor treatment received for at least 4 weeks prior
- ECOG performance status of 0-2
- Estimated life expectancy more than 12 weeks
- Hematology: neutrophils 65 1.5�d710^9/L, lymphocytes 65 0.8�d710^9/L, hemoglobin 65 100 g/L, platelets 65 75 �d710^9/L
- Blood biochemistry: total bilirubin 64 2�d7 upper limit of normal, alanine aminotransferase 64 3�d7 upper limit of normal, aspartate aminotransferase 64 3�d7 upper limit of normal, creatinine clearance 65 lower limit of normal (Cockcroft-Gault formula)
- Willing to participate and provide written informed consent
You will not qualify if you...
- Evidence of central nervous system involvement
- Prior adoptive cell therapy
- Any uncontrolled active infection including HBV, HCV, HIV, or positive treponema pallidum serology
- Received live attenuated vaccine within 3 months
- History of immunodeficiency
- Active autoimmune disease
- Severe conditions such as severe respiratory diseases, severe cardiovascular diseases (including history of CABG/PCI, myocardial infarction/unstable angina, congestive heart failure NYHA III-IV, left ventricular ejection fraction <50%, poorly controlled hypertension within 6 months, QTc interval >480ms, long or short QT syndrome, ventricular arrhythmia), poorly controlled diabetes or metabolic diseases, severe gastrointestinal diseases (severe bleeding, severe diarrhea CTCAE 62 2, or obstruction requiring intervention)
- Possible severe adverse events, allergies or contraindications to study drugs or components
- Pregnant or lactating women
- History of neurological or psychological disorders
- Judged unsuitable for participation by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Changhai Hospital
Shanghai, China, 200433
Actively Recruiting
Research Team
Y
Yanfang Liu, MD PhD
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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