This is a single-center, single-arm, open-label, dose-escalation clinical study to evaluate the safety and anti-tumor efficacy of intratumoral NKG2D CAR-NK cell injection guided by endoscopic ultrasound in the treatment of locally advanced pancreatic cancer.
18~75 years old (including boundary value), both male and female.
Histologically or cytologically confirmed pancreatic ductal adenocarcinoma or IPMN carcinogenesis.
Recurrent or unresectable locally advanced pancreatic cancer. Patients with technically resectable tumors but are considered as unable to undergo surgical treatment due to medical comorbidities or the patient's refusal of surgery are also eligible for enrollment.
ECOG PS score of 0-1.
Pregnant and lactating females.
Received any anti-tumor therapy (including but not limited to radiotherapy, chemotherapy, or immunotherapy) for pancreatic cancer within 28 days prior to enrollment.
In the opinion of the investigator, the EUS technique poses undue risks to the subject, including but not limited to: - Previous EUS-FNA was technically deemed too difficult to perform; - Imaging showing multiple collateral vessels around or near the target tumor within the pancreas; - Presence of varicose veins near the target tumor. - If any of the above risk profiles become apparent after subject screening and/or enrollment, consideration should be given to withdrawal from the study prior to treatment.
History of malignancy within 5 years, with the exception of basal cell carcinoma of the skin and carcinoma in situ of the cervix.
Single group
CAR-NK
Biological/VaccineEndoscopic ultrasound-guided intratumoral CAR-NK injection once at day 0, combined with intravenous CAR-NK infusion twice at day 4 and 5
Maximum tolerated dose
Determine the optimal agent for NKG2D CAR-NK at maximum tolerated dose
Dose limiting toxicity
Describe the adverse events of limiting further increases in the dose of NKG2D CAR-NK
Effectiveness evaluation
Objective Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1
Cell continued survival time in vivo
Detect the copy number of NKG2D CAR DNA in peripheral blood at each visit point after the end of the infusion, until any 2 consecutive test results were negative
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