Endoscopic Ultrasound (EUS) Intratumoral Injection of CAR-NK Cells in the Treatment of Advanced P… (NCT06478459) | Clinical Trial Compass
UnknownEarly Phase 1
Endoscopic Ultrasound (EUS) Intratumoral Injection of CAR-NK Cells in the Treatment of Advanced Pancreatic Cancer
China20 participantsStarted 2024-06-09
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 18\~75 years old (including boundary value), both male and female.
. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma or IPMN carcinogenesis.
. Recurrent or unresectable locally advanced pancreatic cancer. Patients with technically resectable tumors but are considered as unable to undergo surgical treatment due to medical comorbidities or the patient\'s refusal of surgery are also eligible for enrollment.
. ECOG PS score of 0-1.
. At least 3 months of life expectancy at screening, as judged by the investigator.
. Subject has adequate organ and bone marrow function. Laboratory screening results should be within the stable range described below, and there should be no ongoing supportive care (\"jaundice relieve\" therapy such as PTCD, ENBD, or bile duct stenting is allowed when pancreatic cancer invades the common bile duct). a) Blood biochemistry: serum creatinine ≤ 1.5×ULN, serum total bilirubin ≤ 2.0×ULN, and serum liver aminotransferase ≤ 3 ×ULN b) Blood tests: neutrophil count ≥ 1.5×109/L, platelet count ≥ 60×109/L, hemoglobin ≥ 8.0g/dL, lymphocyte count ≥ 0.4×109/L;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum tolerated dose
Timeframe: within 28 days after NKG2D CAR-NK treatment
2
Dose limiting toxicity
Timeframe: From enrollment of the first subject to completion of follow-up of the last subject（up to 2 years））
. Childbearing status: not pregnant and, if of childbearing potential, willing to use effective contraception from the time of signing the informed consent form until 6 months after the last cell infusion (women of childbearing potential include premenopausal women and women within 2 years of postmenopausal time).
. Subjects must sign a written informed consent form.
Exclusion criteria
. Pregnant and lactating females.
. Received any anti-tumor therapy (including but not limited to radiotherapy, chemotherapy, or immunotherapy) for pancreatic cancer within 28 days prior to enrollment.
. In the opinion of the investigator, the EUS technique poses undue risks to the subject, including but not limited to: - Previous EUS-FNA was technically deemed too difficult to perform; - Imaging showing multiple collateral vessels around or near the target tumor within the pancreas; - Presence of varicose veins near the target tumor. - If any of the above risk profiles become apparent after subject screening and/or enrollment, consideration should be given to withdrawal from the study prior to treatment.
. History of malignancy within 5 years, with the exception of basal cell carcinoma of the skin and carcinoma in situ of the cervix.
. Any other health condition by the judgment of the investigator would preclude participation in the study.