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

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

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer Non-resectable
• Intervention / Treatment: Biological: chemotherapy sequential CAR-NK cell infusion

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Qi Zhang; Phone Number: 8613858108798; Email: qi.zhang@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • the first affiliated hospital of Zhejiang University，school of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).
• 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.
• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chemotherapy Sequential NKG2D CAR-NK Cell	Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum tolerated dose	Determine the optimal agent for NKG2D CAR-NK at maximum tolerated dose	within 28 days after NKG2D CAR-NK treatment
Dose limiting toxicity	Describe the adverse events of limiting further increases in the dose of NKG2D CAR-NK	From enrollment of the first subject to completion of follow-up of the last subject up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness evaluation	Objective Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1	At weeks 4、8 and months 3、6、9、12、16、20 and 24 after treatment

Collaborators and Investigators

• Sponsor: Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2024
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: July 9, 2024
• First Submitted That Met QC Criteria: July 9, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 21, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: IIT-C1/22A1-08-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No