Clinical trial NCT06503497: A Trail of Second-line Chemotherapy Sequential NKG2D CAR-NK Cell Therapy for Pancreatic Cancer
Official title: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Pancreatic Cancer Non-resectable
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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 (\&#34;yellowing\&#34; 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.

Primary outcomes:
measure: Maximum tolerated dose
timeFrame: within 28 days after NKG2D CAR-NK treatment
measure: Dose limiting toxicity
timeFrame: From enrollment of the first subject to completion of follow-up of the last subject up to 2 years
Secondary outcomes:
measure: Effectiveness evaluation
timeFrame: At weeks 4、8 and months 3、6、9、12、16、20 and 24 after treatment
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: the first affiliated hospital of Zhejiang University，school of medicine
state: Zhejiang
Study officials:
References: