This is a single-center, open-label, first-in-human, dose-escalation study in patients with pancreatic cancer.
A dose-escalation study will evaluate the safety, tolerability and efficacy of CAR-NK cells (CL-NK-001) in patients with locally advanced, metastatic, or recurrent pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Dose level 1 (5 × 10\^8 cells); dose level 2 (15 × 10\^8 cells); dose level 3 (30 × 10\^8 cells); additional dose levels (investigator's discretion).
Changhai Hospital
Shanghai, China
RECRUITINGDose-limiting toxicity (DLT)
Safety
Time frame: 42 days of first infusion
Maximum tolerated dose (MTD)
Tolerability
Time frame: 42 days of first infusion
Treatment-emergent adverse event (TEAE) and treatment-emergent serious adverse event (TESAE)
Safety
Time frame: 42 days of first infusion
Number of participants with abnormal clinical laboratory parameters reported as TEAE
Safety
Time frame: 42 days of first infusion
Number of participants with abnormal vital signs reported as TEAE
Safety
Time frame: 42 days of first infusion
Number of participants with change from baseline in QT/QTc interval in electrocardiogram
Safety
Time frame: 42 days of first infusion
Objective response rate (ORR)
Efficacy
Time frame: 42 days of first infusion
Disease control rate (DCR)
Efficacy
Time frame: 42 days of first infusion
Progression-free survival (PFS)
Efficacy
Time frame: 6 months
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Overall survival (OS)
Efficacy
Time frame: 6 months
Patient-reported quality of life (QoL)
Measured by the European Organization for Research and Treatment of Cancer quality-of-life questionnaire (EORTC QLQ-C30)
Time frame: 42 days of first infusion
Patient-generated subjective global assessment (PG-SGA)
Nutritional status measurement with a medical history section assessed by patients and a physical assessment section assessed by medical staff
Time frame: 42 days of first infusion