Pancreatic CancerPhase 1NCT05911217
A Study to Evaluate the Efficacy and Safety of CT041 After Adjuvant Chemotherapy for Pancreatic Cancer
A Phase 1 study testing CT041 autologous CAR T-cell injection in people with Pancreatic Cancer, run by CARsgen Therapeutics Co., Ltd. at 8 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- CT041 autologous CAR T-cell injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 8 sitesChina
- Study dates
- 11 Jul 2023to 31 Dec 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- Histologically confirmed pancreatic ductal adenocarcinoma;
- Macroscopic complete tumor removal ;
- Postoperative pathological stage (pTNM): T1-3, N0-2, M0;
- Immunohistochemistry (IHC) staining of subject's tumor tissue sample is CLDN18.2-positive;
Show all 12Show fewer
- Subjects had recovered from surgery and had received months of standard adjuvant therapy;
- Abnormal of Specific tumor marker level;
- With sufficient venous access for leukapheresis collection;
- ECOG performance status score 0-1;
- Adequate organ function;
- Men and women of childbearing potential must be willing to use effective methods of contraception to prevent pregnancy;
Who cannot join
- Prior neoadjuvant therapy for pancreatic cancer;
- Subjects with borderline resectable pancreatic cancer;
- Present or past history of metastatic or locally recurrent pancreatic cancer;
- Evidence of malignant ascites;
- Subjects had diseases that may interfere with CA19-9 level.
- 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;
Show all 24Show fewer
- Pregnant or lactating women;
- Positive serology for HIV, Treponema pallidum or HCV;
- Any active infections;
- Clinically significant thyroid dysfunction;
- Previous allergy to immunotherapy and related drugs, allergy to CT041 ingredients and other serious allergic history;
- Subjects who may be at high risk for potential digestive tract bleeding or perforation;
- Known active autoimmune disease, including but not limited to, psoriasis or rheumatoid arthritis, or other conditions requiring long-term immunosuppressive therapy;
- Subjects who have a history of organ transplantation or are awaiting organ transplantation;
- Subjects who require anticoagulant therapy;
- Subjects who are receiving or are expected to require long-term antiplatelet therapy during the study;
- 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;
- Previously received any gene-modified cell therapies (including CAR T, TCR T);
- Subjects who have other serious diseases that may restrict them from participating in the study assessed by investigators;
- Subjects with oxygen saturation ≤ 95%;
- Subjects who have signs of central nervous system diseases or clinically significant neurological examination abnormalities;
- 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;
- Vaccination with live attenuated vaccines within 4 weeks prior to apheresis or planned during the study;
- Subjects who are unable to or unwilling to comply with the requirements of the study protocol as assessed by investigators.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality
Lin Shen, PhD, doctorshenlin@sina.cn
- Recruiting
Hunan Provincial People's Hospital
Changsha, Hunan
Wei Cheng, Ph.D, 13974866177@163.com
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
Yiping Mou, Ph.D, yipingmou@126.com
- Recruiting
Ruijin Hospital, affiliated to Shanghai Jiaotong University, school of medicine
Shanghai, Shanghai Municipality, 200025
Jun Zhang, Ph.D, junzhang@188.com
- Recruiting
Fudan University Shanghai Cancer Hospital
Shanghai, Shanghai Municipality, 201321
Xianjun Yu, Ph.D, 02164175590, yuxianjun@fudanpci.org
Jian Zhang, Ph.D, 02164175590, Syner2000@163.com
- Recruiting
Union Hospital, Tongji Medical College, Hua zhong University of Science and Technology
Wuhan, Hubei
Heshui Wu, Ph.D, heshuiwu@hust.edc.cn
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xian, Shanxi
Zheng Wu, woozheng@xjtu.edu.cn
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Xiaobing Chen, Ph.D, zlyychenxb0807@zzu.edu.cn
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Pancreatic Cancer
- Being tested
- CT041 autologous CAR T-cell injection
- Keywords
- Adjuvant therapy, Pancreatic Cancer, Claudin18.2, CLDN18.2, CAR T cell
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT041 autologous CAR T-cell injectionDrug
Also called Single Group Assignment
Treatment with anti-claudin18.2 chimeric antigen receptor T-cell infusion.
| Study group | Role | What they receive |
|---|---|---|
| anti-claudin18.2 chimeric antigen receptor T-cell therapy | Experimental | Not described Receives: Drug: CT041 autologous CAR T-cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival (DFS)
The time from the first infusion to the occurrence of local recurrence/distant metastasis or death from any cause, whichever occurred first.
Measured: Up to 18 months
Secondary outcomes (2)
Incidence of Treatment Related adverse events (AEs), treatment related AEs, AEs of special interest (AESI).
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Measured: Up to 18 months
1 year DFS rate
Proportion of patients alive without local recurrence/distant metastasis 1 year after the first infusion.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2023
- Study start11 Jul 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CARsgen Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fudan University
- Responsible party
- Sponsor
- Investigators
- Xianjun Yu, Ph.D, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911217
- Sponsor's protocol ID
- CT041-ST-05
- Status last verified
- Oct 2026
- First submitted
- 12 Jun 2023
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No