Actively Recruiting
Endoscopic Ultrasound-Guided Intratumoral and Intravenous Injection of NKG2D CAR-NK Cells for Locally Advanced Pancreatic Cancer: A Single-Arm Dose-Escalation Study Evaluating Safety and Anti-Tumor Effects
Led by Zhejiang University · Updated on 2024-12-27
20
Participants Needed
1
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and anti-tumor effects of a special immune cell therapy called NKG2D CAR-NK cells for treating locally advanced pancreatic cancer that cannot be surgically removed. This early-phase, single-center study uses a dose-escalation design to find the best tolerated dose and observe potential treatment responses. The therapy is delivered directly into the tumor under guidance from an endoscopic ultrasound. Participants receive one injection of CAR-NK cells into the tumor at the start of the treatment (day 0) via endoscopic ultrasound. This is combined with two intravenous infusions of CAR-NK cells on days 4 and 5. The study is open-label and includes only one treatment group, focusing on increasing doses to assess safety and effectiveness. During the study, participants will be closely monitored for any side effects or adverse reactions within 28 days after treatment. Researchers will track the maximum tolerated dose and observe any dose-limiting toxicities for up to two years after enrollment. Participants will undergo various laboratory tests and follow-ups to evaluate treatment safety and anti-tumor response throughout the study period.
CONDITIONS
Official Title
Endoscopic Ultrasound (EUS) Intratumoral Injection of CAR-NK Cells in the Treatment of Advanced Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, male or female
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma or IPMN carcinogenesis
- Recurrent or unresectable locally advanced pancreatic cancer, including patients unable or unwilling to undergo surgery
- ECOG performance status score of 0-1
- Life expectancy of at least 3 months at screening
- Adequate organ and bone marrow function with specified blood test values within stable ranges
- Not pregnant and willing to use effective contraception if of childbearing potential
- Signed informed consent form
- Willing and able to comply with treatment, tests, follow-up, and study requirements
You will not qualify if you...
- Pregnant or breastfeeding females
- Received any anti-tumor therapy for pancreatic cancer within 28 days before enrollment
- Conditions making endoscopic ultrasound injection too risky, including difficult prior procedures, collateral vessels, varicose veins near tumor
- History of other malignancies within 5 years except certain skin and cervical cancers
- Any other health condition that would prevent safe participation as judged by investigator
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Trial Site Locations
Total: 1 location
1
the first affiliated hospital of Zhejiang University，school of medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
Q
Qi Zhang, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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