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

Recruiting · NCT06816823 · Interventional (participants receive a specific treatment) · Lead sponsor: Changhai Hospital

Interventions studied

CL-NK-001

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

Age range

18 Years to 70 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 1

Study type

Interventional (participants receive a specific treatment)

Aged 18-70 years;
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;
At least 1 measurable lesion according to RECIST 1.1;
Have not received anti-tumor treatment for at least 4 weeks;
ECOG performance status of 0-2;
Estimated life expectancy more than 12 weeks;
Hematology: neutrophils ≥ 1.5×10\^9/L, lymphocytes ≥ 0.8×10\^9/L, hemoglobin ≥ 100 g/L, and platelets ≥ 75 × 10\^9/L;
Blood biochemistry: total bilirubin ≤ 2×ULN, alanine aminotransferase ≤ 3×ULN, aspartate aminotransferase ≤ 3×ULN, and creatinine clearance ≥ LLN (Cockcroft-Gault formula);
Volunteer to participate in this clinical study and willing to sign written informed consent.

Evidence of central nervous system involvement;
Have received adoptive cell therapy;
Patients with any uncontrolled active infection, including but not limited to: HBV, HCV, HIV, or treponema pallidum serology positive;
Vaccinated with a live attenuated vaccine within 3 months;
History of immunodeficiency;
Active autoimmune disease;
Have severe conditions, including but not limited to: (1) severe respiratory diseases; (2) severe cardiovascular diseases (previous history of CABG/PCI; myocardial infarction/unstable angina pectoris, congestive heart failure of NYHA III-IV, left ventricular ejection fraction \< 50%, or poorly controlled hypertension within 6 months; QTc interval \> 480ms, long or short QT syndrome; previous history of ventrical arrhythmia, or ventrical arrhythmia under anti-arrhythmic drugs/ICD); (3) poorly controlled diabetes and other metabolic diseases; (4) severe gastrointestinal diseases (severe gastrointestinal bleeding, severe diarrhea of CTCAE ≥ 2, or severe gastrointestinal obstruction needing intervention);
Possible severe adverse events, allergy or other contraindications to drugs or its component under study;
Pregnant or lactating women;
History of neurological or psychological disorders;
Not suitable to participate this clinical study judged by the investigator.

1 location listed.