To hear about similar clinical trials, please enter your email below
Trial Title:
A Trail of Second-line Chemotherapy Sequential NKG2D CAR-NK Cell Therapy for Pancreatic Cancer
NCT ID:
NCT06503497
Condition:
Pancreatic Cancer Non-resectable
Conditions: Official terms:
Pancreatic Neoplasms
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
chemotherapy sequential CAR-NK cell infusion
Description:
In each chemotherapy cycle, patients received 2 intravenous infusions of CAR-NK on days 2
and 3 after each chemotherapy was discontinued.
Arm group label:
Chemotherapy Sequential NKG2D CAR-NK Cell
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
Criteria for 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).
-
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
July 31, 2024
Completion date:
July 31, 2026
Lead sponsor:
Agency:
Zhejiang University
Agency class:
Other
Source:
Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06503497
