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Clinical Trial Record

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Clinical Study of Cord Blood-Derived CAR-NK Cells in Gastric Cancer and Pancreatic Cancer

2024-07-19

2025-06-13

2027-06

30

Study Overview

Clinical Study of Cord Blood-Derived CAR-NK Cells in Gastric Cancer and Pancreatic Cancer

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;

N/A

  • Gastric Cancer
  • Pancreas Adenocarcinoma
  • BIOLOGICAL: CB CAR-NK182
  • 2024-105

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2024-06-13  

N/A  

2024-07-29  

2024-06-13  

N/A  

2024-07-31  

2024-06-18  

N/A  

2024-07  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
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 infu

BIOLOGICAL: CB CAR-NK182

  • 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
Primary Outcome MeasuresMeasure DescriptionTime Frame
MTDMaximum Tolerated Dose3 years
DLTDose-Dependent Toxicity3 years
Secondary Outcome MeasuresMeasure DescriptionTime Frame
ORROverall objective tumor response rate3 years
DCRDisease control rate3 years
PFSprogression-free survival3 years
OSoverall survival3 years
DORduration of response3 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Liu Yang, M.D.

Phone Number: 13666601475

Email: yangliuqq2003@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Zhejiang University
  • Hangzhou RongGu Biotechnology Limited Company
  • PRINCIPAL_INVESTIGATOR: Yang Liu, M.D., Zhejiang Provincial People's Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
  • Fanotto V, Cordio S, Pasquini G, Fontanella C, Rimassa L, Leone F, Rosati G, Santini D, Giampieri R, Di Donato S, Tomasello G, Silvestris N, Pietrantonio F, Battaglin F, Avallone A, Scartozzi M, Lutrino ES, Melisi D, Antonuzzo L, Pellegrino A, Torri V, Aprile G. Prognostic factors in 868 advanced gastric cancer patients treated with second-line chemotherapy in the real world. Gastric Cancer. 2017 Sep;20(5):825-833. doi: 10.1007/s10120-016-0681-6. Epub 2016 Dec 27.
  • Tabernero J, Hoff PM, Shen L, Ohtsu A, Shah MA, Cheng K, Song C, Wu H, Eng-Wong J, Kim K, Kang YK. Pertuzumab plus trastuzumab and chemotherapy for HER2-positive metastatic gastric or gastro-oesophageal junction cancer (JACOB): final analysis of a double-blind, randomised, placebo-controlled phase 3 study. Lancet Oncol. 2018 Oct;19(10):1372-1384. doi: 10.1016/S1470-2045(18)30481-9. Epub 2018 Sep 11.
  • Thuss-Patience PC, Shah MA, Ohtsu A, Van Cutsem E, Ajani JA, Castro H, Mansoor W, Chung HC, Bodoky G, Shitara K, Phillips GDL, van der Horst T, Harle-Yge ML, Althaus BL, Kang YK. Trastuzumab emtansine versus taxane use for previously treated HER2-positive locally advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma (GATSBY): an international randomised, open-label, adaptive, phase 2/3 study. Lancet Oncol. 2017 May;18(5):640-653. doi: 10.1016/S1470-2045(17)30111-0. Epub 2017 Mar 23.
  • Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Ruschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. doi: 10.1016/S0140-6736(10)61121-X. Epub 2010 Aug 19.
  • Heinemann V, Ebert MP, Laubender RP, Bevan P, Mala C, Boeck S. Phase II randomised proof-of-concept study of the urokinase inhibitor upamostat (WX-671) in combination with gemcitabine compared with gemcitabine alone in patients with non-resectable, locally advanced pancreatic cancer. Br J Cancer. 2013 Mar 5;108(4):766-70. doi: 10.1038/bjc.2013.62. Epub 2013 Feb 14.
  • Cappell KM, Kochenderfer JN. Long-term outcomes following CAR T cell therapy: what we know so far. Nat Rev Clin Oncol. 2023 Jun;20(6):359-371. doi: 10.1038/s41571-023-00754-1. Epub 2023 Apr 13.
  • Khawar MB, Gao G, Rafiq M, Shehzadi A, Afzal A, Abbasi MH, Sheikh N, Afzal N, Ashraf MA, Hamid SE, Shahzaman S, Kawish N, Sun H. Breaking down barriers: The potential of smarter CAR-engineered NK cells against solid tumors. J Cell Biochem. 2023 Aug;124(8):1082-1104. doi: 10.1002/jcb.30460. Epub 2023 Aug 11.
  • Gowrikumar S, Singh AB, Dhawan P. Role of Claudin Proteins in Regulating Cancer Stem Cells and Chemoresistance-Potential Implication in Disease Prognosis and Therapy. Int J Mol Sci. 2019 Dec 20;21(1):53. doi: 10.3390/ijms21010053.
  • Kyuno D, Takasawa A, Takasawa K, Ono Y, Aoyama T, Magara K, Nakamori Y, Takemasa I, Osanai M. Claudin-18.2 as a therapeutic target in cancers: cumulative findings from basic research and clinical trials. Tissue Barriers. 2022 Jan 2;10(1):1967080. doi: 10.1080/21688370.2021.1967080. Epub 2021 Sep 5.
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The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.

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