Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection

Last updated: June 2, 2025
Sponsor: CARsgen Therapeutics Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Gastric Ulcers

Digestive System Neoplasms

Pancreatic Cancer

Treatment

Physician's Choice(Paclitaxel or Irinotecan or Apatinib or Anti-PD-1 antibody)

CT041 autologous CAR T-cell injection

Clinical Study ID

NCT04581473
CT041-ST-01
  • Ages 18-75
  • All Genders

Study Summary

An open, multicenter, phase Ib/II study to evaluate the efficacy, safety and pharmacokinetics of CT041 autologous CAR T-cell injection in patients with advanced gastric/ gastroesophageal junction adenocarcinoma and pancreatic cancer

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Be willing to participate in a clinical trial, be informed and sign inform consent;and be willing to follow and be able to complete all trial procedures;

  2. Aged 18 to 75 years;

  3. Phase Ib:Patients with pathologically diagnosed advanced gastric/ gastroesophagealjunction adenocarcinoma who have failed at least 2 prior lines treatment; orpatients with pathologically diagnosed advanced pancreatic cancer who have failed atleast 1 prior line treatment ; Phase II:Patients with pathologically diagnosedadvanced gastric/ gastroesophageal junction adenocarcinoma who have failed at least 2 prior lines treatment;

  4. Phase Ib:Tumor tissue samples were positive for CLDN18.2 IHC staining; PhaseII:Tumor tissue samples were positive for CLDN18.2 IHC staining and HER2 expressionwas negative;

  5. Estimated life expectancy >12 weeks;

  6. According to the RECIST 1.1, there is measurable tumor lesions;

  7. ECOG physical status score 0 ~ 1 at screening, within 24 hours prior to apheresis,and at baseline;

  8. Sufficient venous access for mononuclear cell collection;

  9. Unless otherwise specified, patients should meet the certain conditions prior toscreening and pre-treatment and be allowed one week to retest if an abnormallaboratory test does not meet the criteria, and if the criteria are still not met,the screening is considered to have failed;

  10. Female patients of childbearing age must undergo a serum pregnancy test at screeningand prior to pretreatment and the results must be negative, and are willing to use avery effective and reliable method of contraception within 1 year after the laststudy treatment;

  11. Men who have actively sexual intercourse with women with child-bearing potential,must agree to use barrier-based contraception if they have no vasectomy.

Exclusion

Exclusion Criteria:

  1. Pregnant or lactating women;

  2. HIV, Treponema pallidum, HCV serologically positive, EBV-DNA, CMV-DNA or 2019-ncovnucleic acid positive;

  3. Any uncontrollable active infection, including but not limited to activetuberculosis, HBV infection;

  4. The side effects caused by the previous treatment of the subjects did not return toCTCAE ≤1; except hair loss and other tolerable events determined by investigator;

  5. Patients known to have active autoimmune diseases, including but not limited topsoriasis or rheumatoid arthritis, or other diseases requiring long-termimmunosuppressive therapy;

  6. Previously allergic to immunotherapy and related drugs,history of severe allergies,or allergic to components of CT041.

  7. Previously received any gene-modified cell therapies(including CAR-T, TCR-T);

  8. Patients have brain metastasis or symptoms of brain metastasis;

  9. Patients at high risk of hemorrhage or perforation;

  10. Patients requiring anticoagulant therapy;

  11. Patients requiring continuous anti-platelet therapy;

  12. Patients with a history of organ transplantation or awaiting organ transplantation;

  13. Patients who have undergone major surgery or significant trauma within 4 weeks priorto apheresis, or who are expected to undergo major surgery during the study;

  14. Presence of other serious pre-existing medical conditions that may limit patientparticipation in the study;

  15. The investigator assessed that the patient was unable or unwilling to comply withthe requirements of the study protocol;

  16. The patient has a central nervous system disease sign or an abnormal neurologicaltest result with clinical significance;

  17. The patient is currently suffered from or have suffered from other incurablemalignant tumors within previous 3 years, except in situ cervical cancer or skinbasal cell cancer.

Study Design

Total Participants: 192
Treatment Group(s): 2
Primary Treatment: Physician's Choice(Paclitaxel or Irinotecan or Apatinib or Anti-PD-1 antibody)
Phase: 1/2
Study Start date:
October 23, 2020
Estimated Completion Date:
June 30, 2038

Study Description

This study is an open, multicenter, Phase Ib/II clinical trial evaluating chimeric antigen receptor-modified autologous T cells targeting Claudin18.2 (CLDN18.2) (CT041 autologous CAR T) in subjects with CLDN18.2 expression-positive, advanced gastric/esophagogastric conjugate adenocarcinoma that has failed at least 2 prior lines therapy and advanced pancreatic cancer that has failed at least 1 prior line therapy. The purpose is to evaluate the efficacy, safety and pharmacokinetics There are two stages in the study. Phase Ib stage is dose escalation and dose expansion study, and Phase II stage is to verify the efficacy and safety of CT041 treatment.

Connect with a study center

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui
    China

    Site Not Available

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian
    China

    Site Not Available

  • Peking University Shenzhen Hospital

    Shenzhen, Guangzhou
    China

    Site Not Available

  • Harbin medical university Affiliated Cancer Hospital

    Harbin, Heilongjia
    China

    Site Not Available

  • Henan Tumor Hospital

    Zhengzhou, Henan
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan
    China

    Site Not Available

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

    Wuhan, Hubei
    China

    Site Not Available

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu
    China

    Site Not Available

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu
    China

    Site Not Available

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, Jilin
    China

    Site Not Available

  • The First Hospital of China Medical University

    Shenyang, Liaoning
    China

    Site Not Available

  • Shandong Cancer Hospital

    Jinan, Shandong
    China

    Site Not Available

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • Ruijin Hospital, affiliated to Shanghai Jiaotong University, school of medicine

    Shanghai, Shanghai 200025
    China

    Site Not Available

  • Shanghai Zhongshan Hospital

    Shanghai, Shanghai
    China

    Site Not Available

  • Sichuan Cancer Hospital

    Chengdu, Sichuan
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Chengdu, Sichuan
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin 300060
    China

    Site Not Available

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang
    China

    Site Not Available

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hanzhou, Zhejiang
    China

    Site Not Available

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