Trial Title:
A Study to Evaluate the Efficacy and Safety of CT041 After Adjuvant Chemotherapy for Pancreatic Cancer
NCT ID:
NCT05911217
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Conditions: Keywords:
Adjuvant therapy
Pancreatic Cancer
Claudin18.2
CLDN18.2
CAR T cell
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
CT041 autologous CAR T-cell injection
Description:
Treatment with anti-claudin18.2 chimeric antigen receptor T-cell infusion. Up to 3 times
CT041 autologous CAR T-cell injection infusion
Arm group label:
anti-claudin18.2 chimeric antigen receptor T-cell therapy
Other name:
Single Group Assignment
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.
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 T) 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 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;
2. Aged 18 to 79 years;
3. Histologically confirmed pancreatic ductal adenocarcinoma;
4. Macroscopic complete tumor removal (R0 or R1 resection);
5. Postoperative pathological stage (pTNM): T1-3, N0-2, M0;
6. Immunohistochemistry (IHC) staining of subject's tumor tissue sample is
CLDN18.2-positive;
7. Subjects had recovered from surgery and had received 3 months of standard adjuvant
therapy;
8. Abnormal CA19-9 level;
9. With sufficient venous access for leukapheresis collection;
10. ECOG performance status score 0-1;
11. Adequate organ function;
12. Men and women of childbearing potential must be willing to use effective methods of
contraception to prevent pregnancy;
Exclusion Criteria:
1. Prior neoadjuvant therapy for pancreatic cancer;
2. Subjects with borderline resectable pancreatic cancer;
3. Present or past history of metastatic or locally recurrent pancreatic cancer;
4. Evidence of malignant ascites;
5. Subjects had diseases that may interfere with CA19-9 level, including but not
limited to cholangitis, pancreatitis, obstructive jaundice, etc.
6. 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;
7. Pregnant or lactating women;
8. Positive serology for HIV, Treponema pallidum or HCV;
9. Any active infections, including but not limited to active tuberculosis, HBV, EBV,
CMV, COVID-19 infections;
10. Clinically significant thyroid dysfunction;
11. Previous allergy to immunotherapy and related drugs, allergy to CT041 ingredients
and other serious allergic history;
12. Subjects who may be at high risk for potential digestive tract bleeding or
perforation;
13. Known active autoimmune disease, including but not limited to, psoriasis or
rheumatoid arthritis, or other conditions requiring long-term immunosuppressive
therapy;
14. Subjects who have a history of organ transplantation or are awaiting organ
transplantation;
15. Subjects who require anticoagulant therapy;
16. Subjects who are receiving or are expected to require long-term antiplatelet therapy
during the study;
17. 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;
18. Previously received any gene-modified cell therapies (including CAR T, TCR T);
19. Subjects who have other serious diseases that may restrict them from participating
in the study assessed by investigators;
20. Subjects with oxygen saturation ≤ 95%;
21. Subjects who have signs of central nervous system diseases or clinically significant
neurological examination abnormalities;
22. 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;
23. Vaccination with live attenuated vaccines within 4 weeks prior to apheresis or
planned during the study;
24. Subjects who are unable to or unwilling to comply with the requirements of the study
protocol as assessed by investigators.
Gender:
All
Minimum age:
18 Years
Maximum age:
79 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Lin Shen, PhD
Email:
doctorshenlin@sina.cn
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaobing Chen, Ph.D
Email:
zlyychenxb0807@zzu.edu.cn
Facility:
Name:
Union Hospital, Tongji Medical College, Hua zhong University of Science and Technology
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
Heshui Wu, Ph.D
Email:
heshuiwu@hust.edc.cn
Facility:
Name:
Hunan Provincial People's Hospital
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Cheng, Ph.D
Email:
13974866177@163.com
Facility:
Name:
Ruijin Hospital, affiliated to Shanghai Jiaotong University, school of medicine
Address:
City:
Shanghai
Zip:
200025
Country:
China
Status:
Recruiting
Contact:
Last name:
Jun Zhang, Ph.D
Email:
junzhang@188.com
Facility:
Name:
Fudan University Shanghai Cancer Hospital
Address:
City:
Shanghai
Zip:
201321
Country:
China
Status:
Recruiting
Contact:
Last name:
Xianjun Yu, Ph.D
Phone:
02164175590
Email:
yuxianjun@fudanpci.org
Contact backup:
Last name:
Jian Zhang, Ph.D
Phone:
02164175590
Email:
Syner2000@163.com
Facility:
Name:
The First Affiliated Hospital of Xi'an Jiaotong University
Address:
City:
Xian
Country:
China
Status:
Recruiting
Contact:
Last name:
Zheng Wu
Email:
woozheng@xjtu.edu.cn
Facility:
Name:
Zhejiang Provincial People's Hospital
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Yiping Mou, Ph.D
Email:
yipingmou@126.com
Start date:
July 11, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
CARsgen Therapeutics Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
Fudan University
Agency class:
Other
Source:
CARsgen Therapeutics Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05911217
