A Study to Evaluate the Efficacy and Safety of CT041 After Adjuvant Chemotherapy for Pancreatic Cancer
Study Details
Study Description
Brief Summary
An open-label, single-arm, multicenter, Phase Ib clinical trial to evaluate the efficacy and safety of CT041 Autologous CAR T Cell Injection after adjuvant chemotherapy in subjects with pancreatic cancer.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
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Phase 1 |
Detailed Description
This study is an open, multicenter, Phase Ib clinical trial evaluating chimeric antigen receptor-modified autologous T cells targeting Claudin18.2 (CLDN18.2) (CT041 autologous CAR
- in subjects with CLDN18.2 expression-positive pancreatic cancer who has undergone adjuvant chemotherapy. The aim of this study is to evaluate the efficacy, safety of CT041 treatment.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: anti-claudin18.2 chimeric antigen receptor T-cell therapy Experimental: anti-claudin18.2 chimeric antigen receptor T-cell therapy Phase 1b: Evaluate the efficacy and safety of CT041 |
Drug: CT041 autologous CAR T-cell injection
Treatment with anti-claudin18.2 chimeric antigen receptor T-cell infusion. Up to 3 times CT041 autologous CAR T-cell injection infusion
Other Names:
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Outcome Measures
Primary Outcome Measures
- Disease free survival (DFS) [Up to 18 months]
The time from the first infusion to the occurrence of local recurrence/distant metastasis or death from any cause, whichever occurred first.
Secondary Outcome Measures
- Incidence of Treatment Related adverse events (AEs), treatment related AEs, AEs of special interest (AESI). [Up to 18 months]
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
- 1 year DFS rate [Up to 18 months]
Proportion of patients alive without local recurrence/distant metastasis 1 year after the first infusion.
- Metastasis free Survival (MFS) [Up to 18 months]
The time from the first infusion to the occurrence of any pancreatic cancer distant metastases or death from any cause, whichever occurred first.
- Overall Survival (OS) [Up to 18 months]
The time from the first infusion to death of the subject from any cause.
- The phamacokinetics in subjects receiving CT041 infusion in this study [Up to 18 months]
Peak cell expansion, peak expansion, area under the curve (AUC), and duration of cell survival after infusion of CT041 cells.
- The immunogenicity in subjects receiving CT041 infusion in this study [Up to 18 months]
Drug antibody (ADA) positive rate after infusion of CT041 cells.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Voluntary participation in the clinical trial; fully understand, be informed about this study and have signed the ICF; willing to follow and able to complete all study procedures;
-
Aged 18 to 79 years;
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Histologically confirmed pancreatic ductal adenocarcinoma;
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Macroscopic complete tumor removal (R0 or R1 resection);
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Postoperative pathological stage (pTNM): T1-3, N0-2, M0;
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Immunohistochemistry (IHC) staining of subject's tumor tissue sample is CLDN18.2-positive;
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Subjects had recovered from surgery and had received 3 months of standard adjuvant therapy;
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Abnormal CA19-9 level;
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With sufficient venous access for leukapheresis collection;
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ECOG performance status score 0-1;
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Adequate organ function;
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Men and women of childbearing potential must be willing to use effective methods of contraception to prevent pregnancy;
Exclusion Criteria:
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Prior neoadjuvant therapy for pancreatic cancer;
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Subjects with borderline resectable pancreatic cancer;
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Present or past history of metastatic or locally recurrent pancreatic cancer;
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Evidence of malignant ascites;
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Subjects had diseases that may interfere with CA19-9 level, including but not limited to cholangitis, pancreatitis, obstructive jaundice, etc.
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Toxicities caused by previous treatment have not recovered to CTCAE ≤ grade 2, except alopecia and other tolerable events as judged by the investigator or laboratory abnormalities allowed in this study;
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Pregnant or lactating women;
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Positive serology for HIV, Treponema pallidum or HCV;
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Any active infections, including but not limited to active tuberculosis, HBV, EBV, CMV, COVID-19 infections;
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Clinically significant thyroid dysfunction;
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Previous allergy to immunotherapy and related drugs, allergy to CT041 ingredients and other serious allergic history;
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Subjects who may be at high risk for potential digestive tract bleeding or perforation;
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Known active autoimmune disease, including but not limited to, psoriasis or rheumatoid arthritis, or other conditions requiring long-term immunosuppressive therapy;
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Subjects who have a history of organ transplantation or are awaiting organ transplantation;
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Subjects who require anticoagulant therapy;
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Subjects who are receiving or are expected to require long-term antiplatelet therapy during the study;
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Subjects who have experienced major surgery or have significant trauma within 4 weeks before apheresis, or who are expected to undergo major surgery during the study period;
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Previously received any gene-modified cell therapies (including CAR T, TCR T);
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Subjects who have other serious diseases that may restrict them from participating in the study assessed by investigators;
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Subjects with oxygen saturation ≤ 95%;
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Subjects who have signs of central nervous system diseases or clinically significant neurological examination abnormalities;
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Subjects who have other uncured malignant tumors in the past 3 years or at the same time, except those with very low degree of malignancy such as cervical cancer in situ and basal cell carcinoma of skin;
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Vaccination with live attenuated vaccines within 4 weeks prior to apheresis or planned during the study;
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Subjects who are unable to or unwilling to comply with the requirements of the study protocol as assessed by investigators.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Henan Cancer Hospital | Zhengzhou | Henan | China | |
2 | Union Hospital, Tongji Medical College, Hua zhong University of Science and Technology | Wuhan | Hubei | China | |
3 | Hunan Provincial People's Hospital | Changsha | Hunan | China | |
4 | Ruijin Hospital, affiliated to Shanghai Jiaotong University, school of medicine | Shanghai | Shanghai | China | 200025 |
5 | Fudan University Shanghai Cancer Hospital | Shanghai | Shanghai | China | 201321 |
6 | The First Affiliated Hospital of Xi'an Jiaotong University | Xian | Shanxi | China | |
7 | Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang | China |
Sponsors and Collaborators
- CARsgen Therapeutics Co., Ltd.
- Fudan University
Investigators
- Principal Investigator: Xianjun Yu, Ph.D, Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CT041-ST-05