Actively Recruiting
A Study to Evaluate the Efficacy and Safety of CT041 After Adjuvant Chemotherapy for Pancreatic Cancer
Led by CARsgen Therapeutics Co., Ltd. · Updated on 2024-05-28
20
Participants Needed
8
Research Sites
181 weeks
Total Duration
On this page
Sponsors
C
CARsgen Therapeutics Co., Ltd.
Lead Sponsor
F
Fudan University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Efficacy and Safety of CT041 After Adjuvant Chemotherapy for Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with informed consent and ability to complete all study procedures
- Aged 18 to 79 years
- Histologically confirmed pancreatic ductal adenocarcinoma
- Complete tumor removal by surgery (R0 or R1 resection)
- Postoperative pathological stage T1-3, N0-2, M0
- Tumor tissue positive for Claudin18.2 by immunohistochemistry
- Recovered from surgery and completed 3 months of standard adjuvant therapy
- Abnormal CA19-9 tumor marker levels
- Sufficient venous access for leukapheresis
- ECOG performance status score of 0 or 1
- Adequate organ function
- Willingness to use effective contraception if of childbearing potential
You will not qualify if you...
- Prior neoadjuvant therapy for pancreatic cancer
- Borderline resectable pancreatic cancer
- Past or present metastatic or locally recurrent pancreatic cancer
- Presence of malignant ascites
- Diseases interfering with CA19-9 levels such as cholangitis, pancreatitis, or obstructive jaundice
- Unresolved toxicities from prior treatments above grade 2 (except alopecia and tolerable events)
- Pregnant or breastfeeding women
- Positive for HIV, syphilis, or hepatitis C virus
- Active infections including tuberculosis, hepatitis B, Epstein-Barr virus, cytomegalovirus, or COVID-19
- Significant thyroid dysfunction
- Allergy to immunotherapy, CT041 ingredients, or serious allergic history
- High risk for digestive tract bleeding or perforation
- Active autoimmune diseases requiring long-term immunosuppression
- History or pending organ transplantation
- Requirement for anticoagulant or long-term antiplatelet therapy
- Major surgery or significant trauma within 4 weeks before leukapheresis or planned during the study
- Prior gene-modified cell therapies including CAR T or TCR T
- Serious diseases limiting study participation
- Oxygen saturation ≤ 95%
- Central nervous system disease or abnormal neurological exams
- Other untreated malignant tumors within the last 3 years except low-risk cancers
- Live vaccine within 4 weeks before leukapheresis or planned during the study
- Inability or unwillingness to comply with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
2
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
3
Union Hospital, Tongji Medical College, Hua zhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
4
Hunan Provincial People's Hospital
Changsha, Hunan, China
Actively Recruiting
5
Ruijin Hospital, affiliated to Shanghai Jiaotong University, school of medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
6
Fudan University Shanghai Cancer Hospital
Shanghai, Shanghai Municipality, China, 201321
Actively Recruiting
7
The First Affiliated Hospital of Xi'an Jiaotong University
Xian, Shanxi, China
Actively Recruiting
8
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
L
Lifeng Zhang
CONTACT
N
Ning Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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