Pancreatic Cancer Non-resectable
Conditions
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
Interventions
BIOLOGICALchemotherapy 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.
Sponsors
Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum tolerated dose | within 28 days after NKG2D CAR-NK treatment | Determine the optimal agent for NKG2D CAR-NK at maximum tolerated dose |
| Dose limiting toxicity | From enrollment of the first subject to completion of follow-up of the last subject up to 2 years | Describe the adverse events of limiting further increases in the dose of NKG2D CAR-NK |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness evaluation | At weeks 4、8 and months 3、6、9、12、16、20 and 24 after treatment | Objective Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1 |
Countries
China
Contacts
Primary ContactQi Zhang
Outcome results
None listed