This is a single-center, single-arm, open-label, dose-escalation clinical study to evaluate the safety and anti-tumor efficacy of intratumoral NKG2D CAR-NK cell injection guided by endoscopic ultrasound in the treatment of locally advanced pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Endoscopic ultrasound-guided intratumoral CAR-NK injection once at day 0, combined with intravenous CAR-NK infusion twice at day 4 and 5
the first affiliated hospital of Zhejiang University,school of medicine
Hangzhou, Zhejiang, China
RECRUITINGMaximum tolerated dose
Determine the optimal agent for NKG2D CAR-NK at maximum tolerated dose
Time frame: within 28 days after NKG2D CAR-NK treatment
Dose limiting toxicity
Describe the adverse events of limiting further increases in the dose of NKG2D CAR-NK
Time frame: From enrollment of the first subject to completion of follow-up of the last subject(up to 2 years))
Effectiveness evaluation
Objective Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1
Time frame: At weeks 4,8 and months 3,6,9,12,16,20 and 24 after treatment
Cell continued survival time in vivo
Detect the copy number of NKG2D CAR DNA in peripheral blood at each visit point after the end of the infusion, until any 2 consecutive test results were negative
Time frame: At weeks 4,8 and months 3,6,9,12,16,20 and 24 after treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.