Actively Recruiting
A Single-center, Single-arm, Open-label, Dose-escalation Study to Evaluate Safety and Anti-tumor Effects of Second-line Chemotherapy Sequential NKG2D CAR-NK Cell Therapy for Pancreatic Cancer
Led by Zhejiang University · Updated on 2024-12-27
30
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 a new treatment combining second-line chemotherapy with NKG2D CAR-NK cell therapy for pancreatic cancer that cannot be surgically removed. This early phase 1, single-center, single-arm, open-label study aims to find the best tolerated dose and observe treatment-related toxicities in patients who have not responded to prior systemic therapy. Participants receive chemotherapy followed by two intravenous infusions of CAR-NK cells on days 2 and 3 after each chemotherapy cycle is completed. The study uses a dose-escalation approach to carefully monitor safety and treatment effects over time. During the trial, participants will have regular assessments including evaluations for dose-limiting toxicities up to 2 years and effectiveness checks at 4 and 8 weeks, and at 3, 6, 9, 12, 16, 20, and 24 months post-treatment. Researchers will also monitor organ and bone marrow function, target lesion response using imaging criteria, and overall health status. The study lasts up to two years with follow-up to observe long-term safety and treatment impact.
CONDITIONS
Brief Title
A Trail of Second-line Chemotherapy Sequential NKG2D CAR-NK Cell Therapy for Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old, both male and female
- Confirmed pancreatic ductal adenocarcinoma or IPMN carcinosis with failure of first-line systemic therapy
- Zubrod-ECOG-WHO performance status score between 0 and 2
- Life expectancy of at least 3 months
- At least one stable target lesion evaluable by RECIST1.1 criteria
- Adequate organ and bone marrow function without ongoing supportive care, except allowed bile duct stenting procedures
- Toxicities from prior anti-cancer therapy resolved to Grade 0-1 or acceptable levels
- Not pregnant and willing to use effective contraception if of childbearing potential from consent to 6 months after last infusion
- Signed and dated informed consent
- Willing and able to comply with treatment, tests, follow-up, and study requirements
You will not qualify if you...
- Pregnant or breastfeeding females
- Positive for HIV, active syphilis, or active hepatitis C infection (inactive or antibody positive but RNA negative allowed)
- Any active infection requiring treatment including tuberculosis, hepatitis B, EBV, CMV, or COVID-19
- History of other cancers within 5 years except certain skin or cervical cancers
- Any other health conditions judged by investigators to prevent 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 - Duration of chemotherapy cycles with CAR-NK infusions administered after each cycle
Participants receive second-line chemotherapy followed by two intravenous infusions of CAR-NK cells on days 2 and 3 after each chemotherapy cycle is discontinued.
Multiple visits corresponding to chemotherapy cycles and CAR-NK infusions
Duration - Up to 2 years after treatment
Participants are monitored for safety and effectiveness at scheduled visits 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
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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