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

NCT ID: NCT06503497

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-09
• Study Completion Date: 2026-07-31

Brief 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

Conditions

Pancreatic Cancer Non-resectable

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chemotherapy Sequential NKG2D CAR-NK Cell

Group Type: EXPERIMENTAL

chemotherapy sequential CAR-NK cell infusion

Intervention Type: BIOLOGICAL

In each chemotherapy cycle, patients received 2 intravenous infusions of CAR-NK on days 2 and 3 after each chemotherapy was discontinued.

Interventions

chemotherapy sequential CAR-NK cell infusion

In each chemotherapy cycle, patients received 2 intravenous infusions of CAR-NK on days 2 and 3 after each chemotherapy was discontinued.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

TingBo Liang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the first affiliated hospital of Zhejiang University，school of medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qi Zhang

Role: CONTACT

Phone: 8613858108798

Email: qi.zhang@zju.edu.cn

Other Identifiers

IIT-C1/22A1-08-B

Identifier Type: -

Identifier Source: org_study_id