Actively Recruiting
A Single-center, Single-arm, Open-label, Dose-escalation Study of Intratumoral NKG2D CAR-NK Cell Injection Guided by Endoscopic Ultrasound for Locally Advanced Pancreatic Cancer
Led by Zhejiang University · Updated on 2024-12-27
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and anti-tumor effects of intratumoral injection of NKG2D CAR-NK cells guided by endoscopic ultrasound in patients with locally advanced pancreatic cancer that cannot be surgically removed. This early phase 1, single-center, single-arm, open-label study aims to determine the best tolerated dose and monitor any dose-limiting toxicities over up to two years. Participants will receive a one-time intratumoral injection of CAR-NK cells on day 0 using endoscopic ultrasound guidance, followed by two intravenous infusions on days 4 and 5. This dose-escalation study is designed to assess how increasing doses affect safety and potential effectiveness. During the study, participants will undergo regular assessments including laboratory tests and imaging evaluations at weeks 4 and 8, and at months 3, 6, 9, 12, 16, 20, and 24 after treatment. Researchers will monitor cell survival in the body, measure anti-tumor response, and watch for any side effects. The total follow-up period may last up to two years to fully evaluate treatment impact and safety.
CONDITIONS
Brief 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, both males and females
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma or IPMN carcinogenesis
- Recurrent or unresectable locally advanced pancreatic cancer, including technically resectable tumors not suitable for surgery due to medical reasons or patient refusal
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- At least 3 months life expectancy at screening as judged by the investigator
- Adequate organ and bone marrow function with specified laboratory values within stable ranges
- Not pregnant and willing to use effective contraception if of childbearing potential from informed consent until 6 months after last cell infusion
- Signed informed consent form
- Ability and willingness to comply with treatment, tests, follow-up, and study requirements
You will not qualify if you...
- Pregnant or lactating females
- Received any anti-tumor therapy for pancreatic cancer within 28 days before enrollment
- Risks from endoscopic ultrasound including difficult previous procedures, multiple collateral vessels near tumor, or presence of varicose veins near tumor
- History of other malignancy within 5 years except basal cell carcinoma or carcinoma in situ of cervix
- Any other health condition judged by investigator to preclude study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 28 days
Participants receive an endoscopic ultrasound-guided intratumoral CAR-NK injection once at day 0, combined with intravenous CAR-NK infusion twice at day 4 and 5.
1 intratumoral injection visit and 2 intravenous infusion visits within 6 days
Duration - Up to 2 years
Participants are monitored for effectiveness and cell survival at multiple time points after treatment.
Visits at weeks 4, 8 and months 3, 6, 9, 12, 16, 20, and 24 after treatment
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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