Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection
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
1 other identifier
interventional
192
1 country
24
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2020
Longer than P75 for phase_1
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2020
CompletedFirst Posted
Study publicly available on registry
October 9, 2020
CompletedStudy Start
First participant enrolled
October 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2038
ExpectedJune 5, 2025
June 1, 2025
4 years
September 24, 2020
June 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Phase Ib: Incidence of Treatment Related adverse events (AEs)
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)
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
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 Outcomes (10)
Phase Ib: Objective Response Rate (ORR), as assessed by Investigators
Up to 18 months
Phase Ib: Progression-free survival (PFS), as assessed by Investigators
Up to 18 months
Phase Ib：Overall survival (OS)
Up to 18 months
Phase Ib：Duration of response (DOR), as assessed by Investigators
Up to 18 months
Phase Ib：Disease control rate (DCR), as assessed by Investigators
Up to 18 months
- +5 more secondary outcomes
Study Arms (2)
CT041 autologous CAR T-cell injection
EXPERIMENTALTwo stages: Phase 1b: dose escalation and dose expansion; Phase 2: verify CT041 efficacy and safety
Physician's Choice
ACTIVE COMPARATORParticipants will receive physician's choice of treatment in Phase II
Interventions
Up to 3 times CT041 autologous CAR T-cell injection infusion
Physician's choice of any BSC listed above
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CARsgen Therapeutics Co., Ltd.lead
- Peking University Cancer Hospital & Institutecollaborator
- Fudan Universitycollaborator
Study Sites (24)
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Peking University Shenzhen Hospital
Shenzhen, Guangzhou, China
Harbin medical university Affiliated Cancer Hospital
Harbin, Heilongjia, China
Henan Tumor Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Shandong Cancer Hospital
Jinan, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Ruijin Hospital, affiliated to Shanghai Jiaotong University, school of medicine
Shanghai, Shanghai Municipality, 200025, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hanzhou, Zhejiang, China
Related Publications (3)
Qi C, Liu C, Peng Z, Zhang Y, Wei J, Qiu W, Zhang X, Pan H, Niu Z, Qiu M, Qin Y, Fang W, Ye F, Li N, Liu T, Liu A, Zhang X, Hu C, Zhang J, Cui J, Lin X, Wang S, Zhang J, Lin T, Qu X, Yuan X, Gong J, Li J, Gao W, Gai L, Wang Y, Yuan D, Li Z, Shen L. Claudin-18 isoform 2-specific CAR T-cell therapy (satri-cel) versus treatment of physician's choice for previously treated advanced gastric or gastro-oesophageal junction cancer (CT041-ST-01): a randomised, open-label, phase 2 trial. Lancet. 2025 Jun 7;405(10494):2049-2060. doi: 10.1016/S0140-6736(25)00860-8. Epub 2025 May 31.
PMID: 40460847DERIVEDQi C, Zhang P, Liu C, Zhang J, Zhou J, Yuan J, Liu D, Zhang M, Gong J, Wang X, Li J, Zhang X, Li N, Peng X, Liu Z, Yuan D, Baffa R, Wang Y, Shen L. Safety and Efficacy of CT041 in Patients With Refractory Metastatic Pancreatic Cancer: A Pooled Analysis of Two Early-Phase Trials. J Clin Oncol. 2024 Jul 20;42(21):2565-2577. doi: 10.1200/JCO.23.02314. Epub 2024 May 24.
PMID: 38788174DERIVEDQi C, Xie T, Zhou J, Wang X, Gong J, Zhang X, Li J, Yuan J, Liu C, Shen L. CT041 CAR T cell therapy for Claudin18.2-positive metastatic pancreatic cancer. J Hematol Oncol. 2023 Sep 9;16(1):102. doi: 10.1186/s13045-023-01491-9.
PMID: 37689733DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lin Shen, Professor
Peking University Cancer Hospital & Institute
- PRINCIPAL INVESTIGATOR
Xianjun Yu, Professor
Fudan University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2020
First Posted
October 9, 2020
Study Start
October 23, 2020
Primary Completion
October 18, 2024
Study Completion (Estimated)
June 30, 2038
Last Updated
June 5, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share