NCT06503497 A Trail of Second-line Chemotherapy Sequential NKG2D CAR-NK Cell Therapy for Pancreatic Cancer
| NCT ID | NCT06503497 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Zhejiang University |
| Condition | Pancreatic Cancer Non-resectable |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-07-09 |
| Primary Completion | 2025-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2024-07-09 with a primary completion date of 2025-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a single-center, single-arm, open-label, dose-escalation clinical study to evaluate the safety and anti-tumor efficacy of second-line systemic chemotherapy sequential NKG2D CAR-NK cell therapy for pancreatic cancer
Eligibility Criteria
Inclusion Criteria: * 1\. Age between 18\~75 years old (including boundary value), both male and female. * 2\. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma or IPMN carcinosis with at least first-line systemic therapy failure. * 3\. Zubrod-ECOG-WHO score (see Annex 2) on a scale of 0-2. * 4\. Life expectancy of at least 3 months at screening, as judged by the investigator. * 5\. At least one stably evaluable target lesion according to RECIST1.1 criteria. * 6\. Subject has adequate organ and bone marrow function. Laboratory screening results should be within the stable range described below, with no ongoing supportive care (\"yellowing\" therapy such as PTCD, ENBD, or bile duct stenting is allowed when pancreatic cancer invades the common bile duct). * 7\. Remission of all toxicities due to prior antineoplastic therapy to Grade 0\~1 (according to NCI CTCAE version 5.0) or to acceptable levels for inclusion/exclusion criteria. * 8\. Childbearing status: not pregnant, and if of childbearing potential, willing to use effective contraception from the time of signing the informed consent form to 6 months after the last cell infusion (females of childbearing potential include premenopausal females and females within 2 years of postmenopause). * 9\. Subjects must sign and date written informed consent. * 10\. Subjects must be voluntary and able to comply with predetermined treatment regimens, laboratory tests, follow-up, and other study requirements. Exclusion Criteria: * 1\. Pregnant and lactating females. * 2\. Positive serology for HIV, Treponema pallidum or HCV (those who are HCV antibody positive but HCV-RNA negative, stable syphilis and inactive patients can be included). * 3\. Any active infection, including but not limited to active tuberculosis, HBV infection (including HBsAg positive, or HBcAb positive with HBV DNA above the lower limit of laboratory testing), Epstein-Barr virus (EBV) DNA positive, cytomegalovirus (CMV) DNA positive or novel coronavirus (new coronavirus) nucleic acid positive, and other bacterial, viral, or fungal infections requiring drug 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 that, in the judgment of the investigator, would preclude participation in the study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06503497 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Pancreatic Cancer Non-resectable. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06503497 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06503497 currently recruiting?
Yes, NCT06503497 is actively recruiting participants. Contact the research team at qi.zhang@zju.edu.cn for enrollment information.
Where is the NCT06503497 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06503497 clinical trial?
NCT06503497 is sponsored by Zhejiang University. The trial plans to enroll 30 participants.
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