CAR-NK Cells (CL-NK-001) in Pancreatic Cancer
Recruiting now · Phase 1
Conditions studied: Pancreatic Cancer
In brief
This is a single-center, open-label, first-in-human, dose-escalation study in patients with pancreatic cancer.
Key facts
- Study ID
- NCT06816823
- Run by
- Changhai Hospital
- People needed
- 30
- Starts
- 2025-04-07
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2025-06-04
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Changhai Hospital — Shanghai, China (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.