clinical study of cord blood-derived car-nk cells in gastric cancer and pancreatic cancer

Conditions: Gastric Cancer; Pancreas Adenocarcinoma

Summary: main objective: to study the maximum tolerated dose (mtd) and dose-dependent toxicity (dlt) of cord blood-derived car-nk cells (cb car-nk182) targeting claudin18.2 in patients with advanced gastric cancer and advanced pancreatic cancer. secondary objective: to evaluate the efficacy of cb car-nk182 in patients with advanced gastric cancer and advanced pancreatic cancer: overall objective tumor response rate (orr), disease control rate (dcr), progression-free survival (pfs), overall survival (os), duration of response (dor), etc. to evaluate the car-nk amplification and persistence of cb car-nk182 in the blood of patients with advanced gastric cancer and advanced pancreatic cancer;


Eligibility 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.

Keywords: gastric cancer pancreatic adenocarcinoma car-nk claudin18.2