About this trial
This is a single-center, open-label, first-in-human, fixed-dose study in patients with pancreatic cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Aged 18-75 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.
Disqualifiers
1. Evidence of central nervous system involvement;2. Have received adoptive cell therapy;3. Patients with any uncontrolled active infection, including but not limited to: HBV, HCV, HIV, or treponema pallidum serology positive;4. Vaccinated with a live attenuated vaccine within 3 months;5. History of immunodeficiency;6. Active autoimmune disease;7. Regular use of systemic corticosteroids within 2 weeks prior to screening at a dose exceeding prednisone 10 mg/day (or equivalent) on any day; 8. 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);9. Possible severe adverse events, allergy or other contraindications to drugs or its component under study;10. Pregnant or lactating women;11. History of neurological or psychological disorders;12. Not suitable to participate this clinical study judged by the investigator.
Trial design
Single group
Treatments tested in this trial
CL-NK-003
Biological/VaccineFixed-dose (3 × 10\^9 cells)
Treatment groups
Trial outcomes
Primary outcomes
Dose-limiting toxicity (DLT)
Safety
Treatment-emergent adverse event (TEAE) and treatment-emergent serious adverse event (TESAE)
Safety
Number of participants with abnormal clinical laboratory parameters reported as TEAE
Safety
Number of participants with abnormal vital signs reported as TEAE
Safety
Secondary outcomes
Objective response rate (ORR)
Efficacy
Disease control rate (DCR)
Efficacy
Progression-free survival (PFS)
Efficacy
Overall survival (OS)
Efficacy
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Changhai Hospital
Lead sponsor
National Key Laboratory of Immunity and Inflammation
Collaborator