Actively Recruiting
CAR-NK Cells (CL-NK-003) in Pancreatic Cancer
Led by Changhai Hospital · Updated on 2026-02-23
9
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
Sponsors
C
Changhai Hospital
Lead Sponsor
N
National Key Laboratory of Immunity and Inflammation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single-center, open-label, first-in-human, fixed-dose study in patients with pancreatic cancer.
CONDITIONS
Official Title
CAR-NK Cells (CL-NK-003) in Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Diagnosis of locally advanced, metastatic, or recurrent pancreatic cancer with eGR1 positive tumor cells (membrane positive rate >40% and expression intensity ≥2+)
- Failed, intolerant to, or declined standard treatment
- At least one measurable lesion according to RECIST 1.1
- No anti-tumor treatment received within the last 4 weeks
- ECOG performance status of 0 to 2
- Estimated life expectancy greater than 12 weeks
- Blood counts with neutrophils ≥ 1.5×10^9/L, lymphocytes ≥ 0.8×10^9/L, hemoglobin ≥ 100 g/L, and platelets ≥ 75×10^9/L
- Blood biochemistry with total bilirubin ≤ 2 times upper limit of normal, alanine aminotransferase ≤ 3 times upper limit of normal, aspartate aminotransferase ≤ 3 times upper limit of normal, and creatinine clearance ≥ lower limit of normal (Cockcroft-Gault formula)
- Willingness to participate and sign informed consent
You will not qualify if you...
- Evidence of central nervous system involvement
- Prior adoptive cell therapy
- Uncontrolled active infections including hepatitis B, hepatitis C, HIV, or positive syphilis serology
- Vaccination with live attenuated vaccine within 3 months
- History of immunodeficiency
- Active autoimmune disease
- Use of systemic corticosteroids exceeding prednisone 10 mg/day within 2 weeks before screening
- Severe conditions such as severe respiratory or cardiovascular diseases, poorly controlled diabetes or metabolic diseases, severe gastrointestinal diseases
- Known allergy or contraindication to study drugs or components
- Pregnancy or breastfeeding
- History of neurological or psychological disorders
- Investigator judgment deeming participant unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Changhai Hospital
Shanghai, China, 200433
Actively Recruiting
Research Team
X
Xuetao Cao
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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