Second-line chemotherapy combined with NKG2D CAR-NK cell therapy for pancreatic cancer
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
This study is testing a new treatment that combines chemotherapy with a special type of immune cell therapy for people with pancreatic cancer that can't be surgically removed and who haven't had success with their first treatment.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Zhejiang University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06503497 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of a novel treatment approach for patients with non-resectable pancreatic cancer who have failed first-line systemic therapy. It involves administering second-line chemotherapy followed by sequential infusion of NKG2D CAR-NK cells. The study is designed as a single-center, open-label, dose-escalation trial, focusing on assessing anti-tumor efficacy and safety outcomes. Participants will be closely monitored for their response to the treatment and any potential side effects.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-75 with histologically confirmed pancreatic ductal adenocarcinoma or IPMN carcinosis who have experienced failure of first-line therapy.
Not a fit: Patients with pancreatic cancer who have not undergone prior systemic therapy or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced pancreatic cancer who have limited treatment alternatives.
How similar studies have performed: While this approach is innovative, similar studies using CAR-NK cell therapies have shown promise in other cancers, suggesting potential for success in this context.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hangzhou, Zhejiang
- the first affiliated hospital of Zhejiang University，school of medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Qi Zhang
- Email: qi.zhang@zju.edu.cn
- Phone: 8613858108798
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.