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Recruiting Phase 1 NCT06816823

CAR-NK Cells (CL-NK-001) in Pancreatic Cancer

Trial Parameters

Condition Pancreatic Cancer
Sponsor Changhai Hospital
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 30
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2025-04-07
Completion 2025-09
Interventions
CL-NK-001

Brief Summary

This is a single-center, open-label, first-in-human, dose-escalation study in patients with pancreatic cancer.

Eligibility Criteria

Inclusion Criteria: 1. Aged 18-70 years; 2. Locally advanced, metastatic, or recurrent pancreatic cancer, with immunohistochemical detection of eGR1 (membrane positive tumor cell rate \>40% and expression intensity ≥2+), who have failed, been intolerant to or reject standard treatment; 3. At least 1 measurable lesion according to RECIST 1.1; 4. Have not received anti-tumor treatment for at least 4 weeks; 5. ECOG performance status of 0-2; 6. Estimated life expectancy more than 12 weeks; 7. Hematology: neutrophils ≥ 1.5×10\^9/L, lymphocytes ≥ 0.8×10\^9/L, hemoglobin ≥ 100 g/L, and platelets ≥ 75 × 10\^9/L; 8. Blood biochemistry: total bilirubin ≤ 2×ULN, alanine aminotransferase ≤ 3×ULN, aspartate aminotransferase ≤ 3×ULN, and creatinine clearance ≥ LLN (Cockcroft-Gault formula); 9. Volunteer to participate in this clinical study and willing to sign written informed consent. Exclusion Criteria: 1. Evidence of central nervous system involvement; 2. Have received adoptive cell therapy; 3.

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