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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Male or female aged 18-75 years (inclusive);

• Understands and voluntarily signs a written informed consent form, and is willing and able to comply with all trial requirements;

• 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;

• Immunohistochemical (IHC) detection of CLDN18.2, the positive expression of CLDN18.2 in tumors must be ≥ 10%;

• At least 1 measurable lesion according to RECIST 1.1;

• ECOG score is 0-1;

• 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.

Locations
Other Locations
China
Zhejiang Provincial People's Hospital
RECRUITING
Hangzhou
Contact Information
Primary
Liu Yang, M.D.
yangliuqq2003@163.com
13666601475
Time Frame
Start Date: 2024-07-19
Estimated Completion Date: 2027-06
Participants
Target number of participants: 30
Treatments
Experimental: CB CAR-NK182
Set 3 dose groups: dose group 1(2 × 10\^6/kg/time, cell infusion on days 0,7 and 14, respectively, 3 times in total), dose group 2(4 × 10\^6/kg/time, cell infusion on days 0,7 and 14, respectively, 3 times in total), dose group 3(8 × 10\^6/kg/time, cell infusions were performed on days 0,7 and 14, respectively, for a total of 3 times). Each dose will enroll 3-6 subjects, each subject will be observed for at least 28 days after receiving the first dose, and the long-term follow-up period will be 2 years after each patient's first dose infusion.
Related Therapeutic Areas
Sponsors
Collaborators: Zhejiang University, Hangzhou RongGu Biotechnology Limited Company
Leads: Zhejiang Provincial People's Hospital

This content was sourced from clinicaltrials.gov

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