A Trail Of Second-line Chemotherapy Sequential NKG2D CAR-NK Cell Therapy For Pancreatic Cancer

Study Overview

A Trail of Second-line 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

N/A

Pancreatic Cancer Non-resectable

BIOLOGICAL: chemotherapy sequential CAR-NK cell infusion

IIT-C1/22A1-08-B

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-07-09	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-12-21
First Submitted that Met QC Criteria 2024-07-09	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-12-27
First Posted (ACTUAL) 2024-07-16	Results First Posted N/A	Last Verified 2024-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

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.

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.

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Qi Zhang

Phone Number: 8613858108798

Email: qi.zhang@zju.edu.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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