- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04581473
Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection
March 5, 2024 updated by: CARsgen Therapeutics Co., Ltd.
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
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
Study Overview
Status
Recruiting
Detailed 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.
Study Type
Interventional
Enrollment (Estimated)
192
Phase
- Phase 2
- Phase 1
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: Lifeng Zhang, MD
- Phone Number: 86-21-64501828
- Email: lifengzhang@carsgen.com
Study Locations
-
-
Anhui
-
Hefei, Anhui, China
- Recruiting
- Anhui Provincial Cancer Hospital
-
Contact:
- Changlu Hu, Professor
-
-
Beijing
-
Beijing, Beijing, China, 100142
- Recruiting
- Beijing Cancer Hospital
-
Contact:
- Shen Lin, PhD
-
-
Fujian
-
Fuzhou, Fujian, China
- Recruiting
- Fujian Medical University Union Hospital
-
Contact:
- Xiaoyan Lin, Professor
-
-
Guangzhou
-
Shenzhen, Guangzhou, China
- Recruiting
- Peking University Shenzhen Hospital
-
Contact:
- Shubing Wang, Professor
-
-
Heilongjia
-
Harbin, Heilongjia, China
- Recruiting
- Harbin Medical University Affiliated Cancer Hospital
-
Contact:
- Yanqiao Zhang, Professor
-
-
Henan
-
Zhengzhou, Henan, China
- Recruiting
- The First Affiliated Hospital of Zhengzhou University
-
Contact:
- Yanru Qin, Professor
-
Zhengzhou, Henan, China
- Recruiting
- Henan Tumor Hospital
-
Contact:
- Ning Li, Professor
-
-
Hubei
-
Wuhan, Hubei, China
- Recruiting
- Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
-
Contact:
- Xianglin Yuan, Professor
-
-
Jiangsu
-
Nanjing, Jiangsu, China
- Recruiting
- Nanjing Drum Tower Hospital
-
Contact:
- Jia Wei, Professor
-
Suzhou, Jiangsu, China
- Recruiting
- The Second Affiliated Hospital of Soochow University
-
Contact:
- Zhixiang Zhuang
-
Yangzhou, Jiangsu, China
- Recruiting
- Northern Jiangsu People's Hospital
-
Contact:
- Xizhi Zhang, Professor
-
-
Jiangxi
-
Nanchang, Jiangxi, China
- Recruiting
- The Second Affiliated Hospital of Nanchang University
-
Contact:
- Anwen Liu, Professor
-
-
Jilin
-
Changchun, Jilin, China
- Recruiting
- the First Hospital of Jilin University
-
Contact:
- Jiuwei Cui, Professor
-
-
Liaoning
-
Shenyang, Liaoning, China
- Recruiting
- The First Hospital of China Medical University
-
Contact:
- Xiujuan Qu, Professor
-
-
Shandong
-
Jinan, Shandong, China
- Recruiting
- Shandong Cancer Hospital
-
Contact:
- Zuoxing Niu, Professor
-
Qingdao, Shandong, China
- Recruiting
- The Affiliated Hospital of Qingdao University
-
Contact:
- Wensheng Qiu, Professor
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Recruiting
- Fudan University Shanghai Cancer Center
-
Contact:
- Xianjun Yu, Professor
-
Contact:
- Jian Zhang, Professor
-
Shanghai, Shanghai, China
- Recruiting
- Shanghai Zhongshan Hospital
-
Contact:
- Tianshu Liu, Professor
-
Shanghai, Shanghai, China, 200025
- Recruiting
- Ruijin Hospital, affiliated to Shanghai Jiaotong University, school of medicine
-
Contact:
- Jun Zhang, Professor
-
-
Sichuan
-
Chengdu, Sichuan, China
- Recruiting
- Sichuan Cancer Hospital
-
Contact:
- Tongyu Lin, Professor
-
Chengdu, Sichuan, China
- Recruiting
- West China Hospital, Sichuan University
-
Contact:
- Meng Qiu, Professor
-
-
Tianjin
-
Tianjin, Tianjin, China, 300060
- Not yet recruiting
- Tianjin Medical University Cancer Institute And Hospital
-
Contact:
- Yi Ba, Professor
-
-
Zhejiang
-
Hangzhou, Zhejiang, China
- Recruiting
- The First Affiliated Hospital, Zhejiang University School of Medicine
-
Contact:
- Weijia Fang, Professor
-
Hanzhou, Zhejiang, China
- Recruiting
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
-
Contact:
- Hongming Pan, Professor
-
-
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.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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/ gastroesophageal junction adenocarcinoma who have failed at least 2 prior lines treatment; or patients with pathologically diagnosed advanced pancreatic cancer who have failed at least 1 prior line treatment ; Phase II:Patients with pathologically diagnosed advanced 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; Phase II:Tumor tissue samples were positive for CLDN18.2 IHC staining and HER2 expression was 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 to screening and pre-treatment and be allowed one week to retest if an abnormal laboratory 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 screening and prior to pretreatment and the results must be negative, and are willing to use a very effective and reliable method of contraception within 1 year after the last study 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 Criteria:
- Pregnant or lactating women;
- HIV, Treponema pallidum, HCV serologically positive, EBV-DNA, CMV-DNA or 2019-ncov nucleic acid positive;
- Any uncontrollable active infection, including but not limited to active tuberculosis, HBV infection;
- The side effects caused by the previous treatment of the subjects did not return to CTCAE ≤1; except hair loss and other tolerable events determined by investigator;
- Patients known to have active autoimmune diseases, including but not limited to psoriasis or rheumatoid arthritis, or other diseases requiring long-term immunosuppressive 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 prior to apheresis, or who are expected to undergo major surgery during the study;
- Presence of other serious pre-existing medical conditions that may limit patient participation in the study;
- The investigator assessed that the patient was unable or unwilling to comply with the requirements of the study protocol;
- The patient has a central nervous system disease sign or an abnormal neurological test result with clinical significance;
- The patient is currently suffered from or have suffered from other incurable malignant tumors within previous 3 years, except in situ cervical cancer or skin basal cell cancer.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CT041 autologous CAR T-cell injection
Two stages: Phase 1b: dose escalation and dose expansion; Phase 2: verify CT041 efficacy and safety
|
Up to 3 times CT041 autologous CAR T-cell injection infusion
Other Names:
|
Active Comparator: Physician's Choice
Participants will receive physician's choice of treatment in Phase II
|
Physician's choice of any BSC listed above
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase Ib: Incidence of Treatment Related adverse events (AEs)
Time Frame: Up to 18 months
|
Incidence of treatment related AEs, AEs of special interest and serious adverse events(SAEs).
|
Up to 18 months
|
Phase Ib: Identification of Maximum Tolerated Dose (MTD)
Time Frame: day1-day28
|
Incidence of dose-limiting toxicities (DLTs)
|
day1-day28
|
Phase II: Progression-free survival (PFS), as assessed by IRC, of CT041 autologous CAR T-cell injection versus Physician's Choice
Time Frame: Up to 24 months
|
Progression-free survival (PFS) was defined as the time from the date of randomization to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause.
|
Up to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase Ib: Objective Response Rate (ORR), as assessed by Investigators
Time Frame: Up to 18 months
|
The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1.
|
Up to 18 months
|
Phase Ib: Progression-free survival (PFS), as assessed by Investigators
Time Frame: Up to 18 months
|
Progression-free survival (PFS) was defined as the time from the date of first infusion of CT041 to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause.
|
Up to 18 months
|
Phase Ib:Overall survival (OS)
Time Frame: Up to 18 months
|
Overall Survival (OS) was defined as the time from the date of first infusion of CT041 to the date of death due to any cause.
|
Up to 18 months
|
Phase Ib:Duration of response (DOR), as assessed by Investigators
Time Frame: Up to 18 months
|
Duration of response (DOR) is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death.
|
Up to 18 months
|
Phase Ib:Disease control rate (DCR), as assessed by Investigators
Time Frame: Up to 18 months
|
Disease control rate (DCR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR) or Stable disease (SD) based on RECIST version 1.1.
|
Up to 18 months
|
Phase II: Overall survival (OS) of CT041 autologous CAR T-cell injection versus Physician's Choice
Time Frame: Up to 24 months
|
Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause.
|
Up to 24 months
|
Progression-free survival (PFS), as assessed by Investigators, of CT041 autologous CAR T-cell injection versus Physician's Choice
Time Frame: Up to 24 months
|
Progression-free survival (PFS) was defined as the time from the date of randomization to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause.infusion
|
Up to 24 months
|
Phase II:Objective Response Rate (ORR), as assessed by IRC and by Investigators
Time Frame: Up to 24 months
|
The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1.
|
Up to 24 months
|
Phase II: Duration of response (DOR), as assessed by IRC and by Investigators
Time Frame: Up to 24 months
|
Duration of response (DOR) is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death.
|
Up to 24 months
|
Phase II: Disease control rate (DCR), as assessed by IRC and by Investigators
Time Frame: Up to 24 months
|
Disease control rate (DCR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR) or Stable disease (SD) based on RECIST version 1.1.
|
Up to 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Xianjun Yu, Professor, Fudan University
- Principal Investigator: Lin Shen, Professor, Peking University Cancer Hospital & Institute
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 Major Dates
Study Start (Actual)
October 23, 2020
Primary Completion (Estimated)
June 30, 2024
Study Completion (Estimated)
June 30, 2038
Study Registration Dates
First Submitted
September 24, 2020
First Submitted That Met QC Criteria
October 5, 2020
First Posted (Actual)
October 9, 2020
Study Record Updates
Last Update Posted (Estimated)
March 6, 2024
Last Update Submitted That Met QC Criteria
March 5, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Endocrine Gland Neoplasms
- Head and Neck Neoplasms
- Esophageal Diseases
- Pancreatic Diseases
- Adenocarcinoma
- Pancreatic Neoplasms
- Esophageal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Topoisomerase Inhibitors
- Protein Kinase Inhibitors
- Topoisomerase I Inhibitors
- Paclitaxel
- Antibodies
- Irinotecan
- Apatinib
Other Study ID Numbers
- CT041-ST-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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