Injecting CAR-NK cells into tumors for advanced pancreatic cancer treatment

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 EUS in the Treatment of Locally Advanced Pancreatic Cancer.

This study is testing if injecting special immune cells directly into tumors can help people with advanced pancreatic cancer feel better and fight the disease.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Zhejiang University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06478459 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of injecting CAR-NK cells directly into tumors using endoscopic ultrasound guidance for patients with locally advanced pancreatic cancer. It is a single-center, open-label, dose-escalation study that aims to determine the anti-tumor efficacy of this innovative approach. Participants will receive intratumoral injections of CAR-NK cells to assess their response to treatment and overall safety profile.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with unresectable or recurrent locally advanced pancreatic cancer.

Not a fit: Patients with resectable tumors who are eligible for surgical treatment or those with significant comorbidities that prevent participation 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 that is currently difficult to treat.

How similar studies have performed: While this approach is innovative, similar studies using CAR-NK cells have shown promise in other cancers, suggesting potential for success in this context.

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.

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, M.D.

Conditions Pancreatic Cancer Non-resectable