Overview

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

Eligibility

Inclusion Criteria:

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1. Age between 18~75 years old (including boundary value), both male and female.

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       2. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma or
          IPMN carcinosis with at least first-line systemic therapy failure.

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3. Zubrod-ECOG-WHO score (see Annex 2) on a scale of 0-2.

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       4. Life expectancy of at least 3 months at screening, as judged by the
          investigator.

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5. At least one stably evaluable target lesion according to RECIST1.1 criteria.

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       6. Subject has adequate organ and bone marrow function. Laboratory screening
          results should be within the stable range described below, with no ongoing
          supportive care ("yellowing" therapy such as PTCD, ENBD, or bile duct
          stenting is allowed when pancreatic cancer invades the common bile duct).

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       7. Remission of all toxicities due to prior antineoplastic therapy to Grade 0~1
          (according to NCI CTCAE version 5.0) or to acceptable levels for
          inclusion/exclusion criteria.

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       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).

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9. Subjects must sign and date written informed consent.

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      10. Subjects must be voluntary and able to comply with predetermined treatment
          regimens, laboratory tests, follow-up, and other study requirements.

Exclusion Criteria:

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1. Pregnant and lactating females.

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       2. Positive serology for HIV, Treponema pallidum or HCV (those who are HCV
          antibody positive but HCV-RNA negative, stable syphilis and inactive patients
          can be included).

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       3. Any active infection, including but not limited to active tuberculosis, HBV
          infection (including HBsAg positive, or HBcAb positive with HBV DNA above the
          lower limit of laboratory testing), Epstein-Barr virus (EBV) DNA positive,
          cytomegalovirus (CMV) DNA positive or novel coronavirus (new coronavirus)
          nucleic acid positive, and other bacterial, viral, or fungal infections
          requiring drug treatment;

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       4. History of malignancy within 5 years, with the exception of basal cell
          carcinoma of the skin and carcinoma in situ of the cervix.

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       5. Any other health condition that, in the judgment of the investigator, would
          preclude participation in the study.