To hear about similar clinical trials, please enter your email below
Trial Title:
Clinical Study of Cord Blood-Derived CAR-NK Cells in Gastric Cancer and Pancreatic Cancer
NCT ID:
NCT06464965
Condition:
Gastric Cancer
Pancreas Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Stomach Neoplasms
Conditions: Keywords:
Gastric Cancer
Pancreatic Adenocarcinoma
CAR-NK
Claudin18.2
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
CB CAR-NK182
Description:
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
Arm group label:
CB CAR-NK182
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;
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhejiang Provincial People's Hospital
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Liu Yang, M.D.
Phone:
13666601475
Email:
yangliuqq2003@163.com
Investigator:
Last name:
Liu Yang, M.D.
Email:
Principal Investigator
Start date:
July 19, 2024
Completion date:
June 2027
Lead sponsor:
Agency:
Zhejiang Provincial People's Hospital
Agency class:
Other
Collaborator:
Agency:
Zhejiang University
Agency class:
Other
Collaborator:
Agency:
Hangzhou RongGu Biotechnology Limited Company
Agency class:
Other
Source:
Zhejiang Provincial People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06464965
