Actively Recruiting
Study of Second-line Chemotherapy Followed by NKG2D CAR-NK Cell Therapy for Pancreatic Cancer to Evaluate Safety and Anti-Tumor Effects
Led by Zhejiang University · Updated on 2024-12-27
30
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 second-line treatment combining systemic chemotherapy with sequential NKG2D CAR-NK cell therapy in patients with non-resectable pancreatic cancer. This early phase 1, single-center, open-label study focuses on patients who have not responded to first-line systemic therapy. The study aims to find the maximum tolerated dose and monitor dose limiting toxicities of this combined therapy over a follow-up period up to 2 years. Patients receive chemotherapy cycles followed by two intravenous infusions of CAR-NK cells on days 2 and 3 after each chemotherapy is stopped. This dose-escalation design helps determine safe and effective dosing levels. The treatment is delivered sequentially, with careful monitoring throughout the study period. Participants will undergo evaluations to assess safety and anti-tumor response, including assessments of target lesions based on RECIST 1.1 criteria. Laboratory tests will monitor organ and bone marrow function, while toxicity levels from previous therapies must be resolved to acceptable levels before enrollment. Participants will be followed for up to 2 years to assess treatment effects and safety outcomes, including maximum tolerated dose and dose limiting toxicities.
CONDITIONS
Official 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
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma or IPMN carcinosis with failure of at least first-line systemic therapy
- ECOG performance status score between 0 and 2
- Life expectancy of at least 3 months at screening
- At least one stable target lesion evaluable by RECIST 1.1 criteria
- Adequate organ and bone marrow function with stable laboratory results, no ongoing supportive care except allowed bile duct interventions
- Recovery of prior therapy toxicities to Grade 0-1 or acceptable levels
- Not pregnant and willing to use effective contraception if of childbearing potential, from consent signing until 6 months after last infusion
- Signed written informed consent
- Voluntary and able to comply with treatment, tests, follow-up, and study requirements
You will not qualify if you...
- Pregnant or breastfeeding females
- Positive serology for HIV, Treponema pallidum, or active HCV infection (HCV antibody positive but RNA negative, stable syphilis, and inactive patients allowed)
- Any active infection requiring treatment, including tuberculosis, HBV, EBV, CMV, novel coronavirus, or other bacterial, viral, or fungal infections
- History of other malignancies within 5 years except basal cell skin cancer or cervical carcinoma in situ
- Any other health condition judged by the investigator to prevent study participation
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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
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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