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New treatment option for Pancreatic Cancer Non-resectable
Official title A Trail of Second-line Chemotherapy Sequential NKG2D CAR-NK Cell Therapy for Pancreatic Cancer
ClinicalTrials.gov ID: NCT06503497
What this study is testing
What is chemotherapy sequential CAR-NK cell infusion?
chemotherapy sequential CAR-NK cell infusion is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pancreatic cancer non-resectable.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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.
You likely can't join if
- 8\. Childbearing status: not pregnant, and if of childbearing potential, willing to use effective contraception from the time of signing the informed...
- 9\. people must sign and date written informed consent.
- 10\. people 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...
- 3\. Any active infection, including but not limited to active tuberculosis, HBV infection (including HBsAg positive, or HBcAb positive with HBV DNA...
See the full eligibility 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...
- 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/
- 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...
- 9\. people must sign and date written informed consent.
- 10\. people 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)...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.