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Trial Title:
Endoscopic Ultrasound (EUS) Intratumoral Injection of CAR-NK Cells in the Treatment of Advanced Pancreatic Cancer
NCT ID:
NCT06478459
Condition:
Pancreatic Cancer Non-resectable
Conditions: Official terms:
Pancreatic Neoplasms
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
CAR-NK
Description:
Endoscopic ultrasound-guided intratumoral CAR-NK injection once at day 0, combined with
intravenous CAR-NK infusion twice at day 4 and 5
Arm group label:
CAR-NK：intratumoral injection combined with intravenous infusion
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 18~75 years old (including boundary value), both male and female.
2. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma or IPMN
carcinogenesis.
3. 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.
4. ECOG PS score of 0-1.
5. At least 3 months of life expectancy at screening, as judged by the investigator.
6. 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;
7. 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).
8. Subjects must sign a written informed consent form.
9. Subjects must be voluntary and able to comply with the scheduled treatment regimen,
laboratory tests, follow-up, and other study requirements.
Exclusion Criteria:
1. Pregnant and lactating females.
2. Received any anti-tumor therapy (including but not limited to radiotherapy,
chemotherapy, or immunotherapy) for pancreatic cancer within 28 days prior to
enrollment.
3. 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.
4. History of malignancy within 5 years, with the exception of basal cell carcinoma of
the skin and carcinoma in situ of the cervix.
5. Any other health condition by the judgment of the investigator would preclude
participation in the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
June 30, 2024
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Zhejiang University
Agency class:
Other
Source:
Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06478459
