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A Trail of Second-line Chemotherapy Sequential NKG2D CAR-NK Cell Therapy for Pancreatic Cancer | Clinical Trials | Clareo Health

RECRUITINGEARLY_PHASE1

A Trail of Second-line Chemotherapy Sequential NKG2D CAR-NK Cell Therapy for Pancreatic Cancer

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

NCT06503497•Zhejiang University

View on ClinicalTrials.gov

Summary

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

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

Exclusion Criteria

•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.
•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).
•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;
•4\. History of malignancy within 5 years, with the exception of basal cell carcinoma of the skin and carcinoma in situ of the cervix.
•5\. Any other health condition that, in the judgment of the investigator, would preclude participation in the study.

Locations (1)

the first affiliated hospital of Zhejiang University，school of medicine

Hangzhou, Zhejiang, China

Key Dates

Start Date

July 9, 2024

Primary Completion Date

July 31, 2025

Completion Date

July 31, 2026

Last Updated

December 27, 2024

Enrollment

ESTIMATED participants

Conditions

Pancreatic Cancer Non-resectable

Interventions

chemotherapy sequential CAR-NK cell infusion

BIOLOGICAL

Contacts

Qi Zhang

CONTACT

8613858108798 qi.zhang@zju.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 27, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Trail of Second-line Chemotherapy Sequential NKG2D CAR-NK Cell Therapy for Pancreatic Cancer

Inclusion Criteria

Exclusion Criteria

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