Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT07425483

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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Changhai Hospital

Shanghai, China, 200433

Actively Recruiting

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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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