Cord blood cells engineered to fight stomach and pancreatic cancers
NCT ID NCT06464965
First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 3 times
Summary
This early-phase study tested a new treatment using immune cells from cord blood, modified to target a protein called Claudin18.2 found on some cancer cells. Ten adults with advanced stomach or pancreatic cancer who had no other options received these cells to find the safest dose and check for side effects. The goal was to see if this approach could shrink tumors or slow the disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
9 people
The number who actually took part.
- Started
-
Jul 2024
- Finished
-
Dec 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced pancreatic cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a personalized menu keep cancer patients stronger through chemotherapy?
- Nerve-Block procedure tested against severe pancreatic and stomach cancer pain
- Robotic surgery vs standard approaches: does the platform change cancer outcomes?
- Can a direct hit to tumors make immunotherapy work better?
- New antibody aims to preserve immune checkpoint while fighting cancer
- Engineered immune cells target two markers on Hard-to-Treat tumors