Phase
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
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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;
Aged 18 to 75 years;
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;
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;
Estimated life expectancy >12 weeks;
According to the RECIST 1.1, there is measurable tumor lesions;
ECOG physical status score 0 ~ 1 at screening, within 24 hours prior to apheresis,and at baseline;
Sufficient venous access for mononuclear cell collection;
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;
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;
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:
Pregnant or lactating women;
HIV, Treponema pallidum, HCV serologically positive, EBV-DNA, CMV-DNA or 2019-ncovnucleic acid positive;
Any uncontrollable active infection, including but not limited to activetuberculosis, HBV infection;
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;
Patients known to have active autoimmune diseases, including but not limited topsoriasis or rheumatoid arthritis, or other diseases requiring long-termimmunosuppressive therapy;
Previously allergic to immunotherapy and related drugs,history of severe allergies,or allergic to components of CT041.
Previously received any gene-modified cell therapies(including CAR-T, TCR-T);
Patients have brain metastasis or symptoms of brain metastasis;
Patients at high risk of hemorrhage or perforation;
Patients requiring anticoagulant therapy;
Patients requiring continuous anti-platelet therapy;
Patients with a history of organ transplantation or awaiting organ transplantation;
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;
Presence of other serious pre-existing medical conditions that may limit patientparticipation in the study;
The investigator assessed that the patient was unable or unwilling to comply withthe requirements of the study protocol;
The patient has a central nervous system disease sign or an abnormal neurologicaltest result with clinical significance;
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
Study Description
Connect with a study center
Anhui Provincial Cancer Hospital
Hefei, Anhui
ChinaSite Not Available
Beijing Cancer Hospital
Beijing, Beijing 100142
ChinaSite Not Available
Fujian Medical University Union Hospital
Fuzhou, Fujian
ChinaSite Not Available
Peking University Shenzhen Hospital
Shenzhen, Guangzhou
ChinaSite Not Available
Harbin medical university Affiliated Cancer Hospital
Harbin, Heilongjia
ChinaSite Not Available
Henan Tumor Hospital
Zhengzhou, Henan
ChinaSite Not Available
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
ChinaSite Not Available
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei
ChinaSite Not Available
Nanjing Drum Tower Hospital
Nanjing, Jiangsu
ChinaSite Not Available
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu
ChinaSite Not Available
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu
ChinaSite Not Available
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
ChinaSite Not Available
The First Hospital of Jilin University
Changchun, Jilin
ChinaSite Not Available
The First Hospital of China Medical University
Shenyang, Liaoning
ChinaSite Not Available
Shandong Cancer Hospital
Jinan, Shandong
ChinaSite Not Available
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
ChinaSite Not Available
Fudan University Shanghai Cancer Center
Shanghai, Shanghai 200032
ChinaSite Not Available
Ruijin Hospital, affiliated to Shanghai Jiaotong University, school of medicine
Shanghai, Shanghai 200025
ChinaSite Not Available
Shanghai Zhongshan Hospital
Shanghai, Shanghai
ChinaSite Not Available
Sichuan Cancer Hospital
Chengdu, Sichuan
ChinaSite Not Available
West China Hospital, Sichuan University
Chengdu, Sichuan
ChinaSite Not Available
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin 300060
ChinaSite Not Available
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
ChinaSite Not Available
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hanzhou, Zhejiang
ChinaSite Not Available

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