Last updated: December 21, 2024
Sponsor: Zhejiang University
Overall Status: Active - Recruiting
Phase
1
Condition
Digestive System Neoplasms
Treatment
chemotherapy sequential CAR-NK cell infusion
Clinical Study ID
NCT06503497
IIT-C1/22A1-08-B
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age between 18~75 years old (including boundary value), both male and female.
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma orIPMN carcinosis with at least first-line systemic therapy failure.
- Zubrod-ECOG-WHO score (see Annex 2) on a scale of 0-2.
- Life expectancy of at least 3 months at screening, as judged by theinvestigator.
- At least one stably evaluable target lesion according to RECIST1.1 criteria.
- Subject has adequate organ and bone marrow function. Laboratory screeningresults should be within the stable range described below, with no ongoingsupportive care ("yellowing" therapy such as PTCD, ENBD, or bile ductstenting is allowed when pancreatic cancer invades the common bile duct).
- Remission of all toxicities due to prior antineoplastic therapy to Grade 0~1 (according to NCI CTCAE version 5.0) or to acceptable levels forinclusion/exclusion criteria.
- Childbearing status: not pregnant, and if of childbearing potential, willing touse effective contraception from the time of signing the informed consent formto 6 months after the last cell infusion (females of childbearing potentialinclude premenopausal females and females within 2 years of postmenopause).
- Subjects must sign and date written informed consent.
- Subjects must be voluntary and able to comply with predetermined treatmentregimens, laboratory tests, follow-up, and other study requirements.
Exclusion
Exclusion Criteria:
- Pregnant and lactating females.
- Positive serology for HIV, Treponema pallidum or HCV (those who are HCVantibody positive but HCV-RNA negative, stable syphilis and inactive patientscan be included).
- Any active infection, including but not limited to active tuberculosis, HBVinfection (including HBsAg positive, or HBcAb positive with HBV DNA above thelower 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 infectionsrequiring drug treatment;
- History of malignancy within 5 years, with the exception of basal cellcarcinoma of the skin and carcinoma in situ of the cervix.
- Any other health condition that, in the judgment of the investigator, wouldpreclude participation in the study.
Study Design
Total Participants: 30
Treatment Group(s): 1
Primary Treatment: chemotherapy sequential CAR-NK cell infusion
Phase: 1
Study Start date:
July 09, 2024
Estimated Completion Date:
July 31, 2026
Connect with a study center
the first affiliated hospital of Zhejiang University,school of medicine
Hangzhou, Zhejiang 310009
ChinaActive - Recruiting

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