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

NCT06503497 | Recruiting Early Phase 1

• 1 other identifier: IIT-C1/22A1-08-B
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Effectiveness evaluation

  At weeks 4、8 and months 3、6、9、12、16、20 and 24 after treatment

Study Arms (1)

Chemotherapy Sequential NKG2D CAR-NK Cell

EXPERIMENTAL

Biological: chemotherapy sequential CAR-NK cell infusion

Interventions

chemotherapy sequential CAR-NK cell infusion BIOLOGICAL

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

Chemotherapy Sequential NKG2D CAR-NK Cell

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age between 18\~75 years old (including boundary value), both male and female.
• \. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma or IPMN 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 the investigator.
• \. At least one stably evaluable target lesion according to RECIST1.1 criteria.
• \. 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).

You may not qualify if:

• \. 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).
• \. Subjects must sign and date written informed consent.
• \. Subjects must be voluntary and able to comply with predetermined treatment regimens, laboratory tests, follow-up, and other study requirements.
• \. Pregnant and lactating females.
• \. 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).
• \. 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;
• \. History of malignancy within 5 years, with the exception of basal cell carcinoma of the skin and carcinoma in situ of the cervix.
• \. Any other health condition that, in the judgment of the investigator, would preclude participation in the study.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

the first affiliated hospital of Zhejiang University，school of medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

Central Study Contacts

Qi Zhang

CONTACT

8613858108798; qi.zhang@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 16, 2024
• Study Start: July 9, 2024
• Primary Completion: July 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: December 27, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)