Using cord blood-derived CAR-NK cells to treat advanced gastric and pancreatic cancer
A Phase I Clinical Study of Cord Blood-Derived CAR-NK Cells Targeting Claudin18.2 in the Treatment of Advanced Gastric Cancer and Advanced Pancreatic Cancer
This study is testing if a new treatment using special immune cells from cord blood can help people with advanced stomach and pancreatic cancer who haven't had success with regular treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Zhejiang Provincial People's Hospital Academic / other |
| Drugs / interventions | CAR-T |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06464965 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to evaluate the maximum tolerated dose and dose-dependent toxicity of cord blood-derived CAR-NK cells targeting Claudin18.2 in patients with advanced gastric and pancreatic cancers. It will also assess the efficacy of these CAR-NK cells by measuring overall tumor response rates, disease control rates, and survival outcomes. Patients will be monitored for the persistence and amplification of these cells in their bloodstream. The study is designed for individuals who have not responded to standard treatments or cannot tolerate them.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with advanced gastric or pancreatic cancer that expresses Claudin18.2 and have failed or cannot tolerate standard treatments.
Not a fit: Patients with early-stage cancer or those without Claudin18.2 expression in their tumors 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 gastric and pancreatic cancers who have limited treatment choices.
How similar studies have performed: While the use of CAR-NK cells is a novel approach, similar studies targeting other cancers have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female aged 18-75 years (inclusive); 2. Understands and voluntarily signs a written informed consent form, and is willing and able to comply with all trial requirements; 3. Patients with advanced gastric cancer and advanced pancreatic cancer confirmed by histopathology or cytology, who have failed standard treatment or cannot tolerate standard treatment, including but not limited to: pancreatic cancer and gastric cancer; 4. Immunohistochemical (IHC) detection of CLDN18.2, the positive expression of CLDN18.2 in tumors must be ≥ 10%; 5. At least 1 measurable lesion according to RECIST 1.1; 6. ECOG score is 0-1; 7. All toxic reactions caused by previous antineoplastic therapy were resolved to grade 0-1 (according to NCI CTCAE 5.0 edition); Expected survival ≥ 12 weeks; In addition to the primary disease, no serious hematology, heart and lung, liver and kidney disease, laboratory tests meet the following requirements: Peripheral blood neutrophil absolute value ≥ 2000/mm3, platelet ≥ 50000/mm3 Serum creatinine ≤ 1.5mg/dL;ALT (alanine aminotransferase)/AST (aspartate aminotransferase) below 2.5 times the upper limit of normal; Total bilirubin ≤ 1.5mg/dL; Cardiac ejection fraction (EF)≥ 50%; International standard ratio (INR) or prothrombin time (PT) below 1.5 times the upper limit of normal; Activated partial coagulation time (aPTT) below 1.5 times the upper limit of normal; 10. Women of childbearing potential must have a negative serum pregnancy test and agree to effective birth control during the treatment phase and within 12 months after injection of CAR-NK cells; Male patients must agree to use effective birth control during the study and for 12 months after injection of CAR-NK cells. Exclusion Criteria: 1. History of other tumors; 2. Patients who have received CAR-T,CAR-NK,TCR-T and other cell therapy targeting Claudin18.2 within 3 months before study treatment; 3. Patients with hypersensitivity to cell therapy or any related drugs; 4. Active autoimmune diseases; 5. Active infections that cannot be controlled; 6. HIV infection, uncontrolled HBV, HCV and syphilis infections; 7. Have metastatic disease of the central nervous system (CNS), leptomeningeal disease or spinal cord compression; 8. Patients with severe heart disease; 9. Patients with unstable/active ulcers or bleeding from the digestive system; 10. Patients with a history of bleeding or bleeding tendency in the digestive system; 11. Pregnant or lactating women; 12. There are other factors that the researcher believes are not suitable for participating in the trial.
Where this trial is running
Hangzhou, Zhejiang
- Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Yang Liu, M.D. — Zhejiang Provincial People's Hospital
- Study coordinator: Liu Yang, M.D.
- Email: yangliuqq2003@163.com
- Phone: 13666601475
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.