This is a single-center, single-arm, open-label, dose-escalation clinical study to evaluate the safety and anti-tumor efficacy of second-line systemic chemotherapy sequential NKG2D CAR-NK cell therapy for pancreatic cancer
1. Age between 18~75 years old (including boundary value), both male and female.
2. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma or IPMN carcinosis with at least first-line systemic therapy failure.
3. Zubrod-ECOG-WHO score (see Annex 2) on a scale of 0-2.
4. Life expectancy of at least 3 months at screening, as judged by the investigator.
8. Childbearing status: not pregnant, and if of childbearing potential, willing to use effective contraception from the time of signing the informed consent form to 6 months after the last cell infusion (females of childbearing potential include premenopausal females and females within 2 years of postmenopause).
9. Subjects must sign and date written informed consent.
10. Subjects must be voluntary and able to comply with predetermined treatment regimens, laboratory tests, follow-up, and other study requirements.
1. Pregnant and lactating females.
Single group
chemotherapy sequential CAR-NK cell infusion
Biological/VaccineIn each chemotherapy cycle, patients received 2 intravenous infusions of CAR-NK on days 2 and 3 after each chemotherapy was discontinued.
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
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