Actively Recruiting
Phase I Clinical Study of Chimeric Antigen Receptor T Cells (C-13-60) for CEA Positive Advanced Malignant Solid Tumors
Led by Chongqing Precision Biotech Co., Ltd · Updated on 2023-09-21
30
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
C
Chongqing Precision Biotech Co., Ltd
Lead Sponsor
Z
Zhejiang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the use of C-13-60 cells, a type of chimeric antigen receptor T cell therapy (CAR-T), for treating patients with advanced malignant solid tumors that test positive for carcinoembryonic antigen (CEA). This phase I, single-arm, open-label trial aims to assess the safety, tolerability, and how the drug behaves in the body, while also making early observations on its effectiveness. The study focuses on finding the appropriate dose for future phase II trials in various cancers including colorectal, esophageal, gastric, pancreatic, non-small cell lung, breast, and bile duct cancers. Participants will receive intravenous infusions of CEA-targeted CAR-T cells, with doses increasing stepwise from 2 to 10 million cells per kilogram of body weight. Before the cell infusion, patients undergo conditioning chemotherapy with Fludarabine and Cyclophosphamide to prepare the body. The dose escalation follows strict safety rules: groups of patients receive increasing doses, and if severe toxicity occurs, the treatment is adjusted or stopped based on safety committee decisions. The trial includes a 28-day period of monitoring for dose-limiting toxicities after each infusion. Throughout the study, participants will have regular evaluations including tumor assessments, laboratory tests, and monitoring of cell levels in the blood. Researchers will track safety outcomes such as dose-limiting toxicities and maximum tolerated dose within one month. They will also measure disease control rates and various pharmacokinetic indicators over three months. The trial requires participants to agree to contraception use and undergo follow-up to evaluate treatment impact and safety. The overall study duration extends until the end of 2027, with detailed monitoring during and after treatment.
CONDITIONS
Brief Title
A Clinical Trial Targeting CEA Chimeric Antigen Receptor T (CAR-T) for CEA Positive Advanced Malignant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, male or female
- Diagnosed with advanced malignant solid tumors confirmed by histology or pathology, including colorectal, esophageal, gastric, pancreatic, non-small cell lung, breast, or bile duct cancers
- Disease progression or intolerance after standard systemic therapies, with specific line therapy requirements depending on cancer type
- Positive carcinoembryonic antigen (CEA) expression in tumor tissue within 3 months prior to screening or confirmed by blood serum CEA levels
- At least one evaluable target lesion according to RECIST 1.1 criteria
- ECOG performance status 0 to 1 for most cancers; 0 to 2 for pancreatic cancer
- Expected survival time greater than 12 weeks
- No serious mental disorders
- Adequate vital organ function as defined by blood counts, cardiac, renal, liver function, and oxygen saturation
- Eligible for blood collection and no contraindications for cell collection
- Agree to use reliable contraception for 1 year following infusion
- Provide informed consent and willingness to participate in the trial
You will not qualify if you...
- Prior treatment with CAR-T or other gene-modified cell therapies
- Brain metastatic disease with clinical symptoms or lesions in critical brain areas
- Use of investigational drugs within 4 weeks prior to screening
- Live attenuated vaccine within 4 weeks prior to screening
- Radioactive iodine-125 particle implantation within 8 weeks prior to screening
- Use of systemic steroids or anti-PD-1/PD-L1 therapies close to apheresis
- Active or uncontrolled infections requiring systemic treatment within 1 week prior to screening
- Severe gastrointestinal conditions such as obstruction or recent massive bleeding
- History of severe respiratory diseases
- Large uncontrollable serous effusions
- Significant heart conditions including advanced heart failure or recent myocardial infarction
- Active autoimmune diseases requiring immunosuppressive treatment
- Positive tests for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus with abnormal viral loads
- Venous embolism events requiring anticoagulation at screening
- Other untreated malignancies within past 3 years except certain skin and cervical cancers
- Pregnancy, nursing, or plans to conceive within 1 year post-infusion
- Any other conditions deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 to 5 days
Participants receive conditioning chemotherapy with Fludarabine and Cyclophosphamide 1 to 5 days prior to CAR-T cell infusion to prepare for treatment.
1 to 2 visits depending on chemotherapy schedule
Duration - 28 days per infusion cycle, repeated with dose escalation until DLT occurs or maximum dose is reached
Participants receive intravenous infusion of CEA-targeted CAR-T cells by escalating doses according to the study protocol. Dose escalation proceeds based on safety and dose-limiting toxicity (DLT) observations.
Multiple visits for infusions and monitoring during each 28-day cycle
Duration - Up to 3 months
Participants are monitored for safety, tolerability, and effectiveness outcomes including disease control rate and cell dynamics for up to 3 months after the last infusion.
Regular visits for safety and efficacy assessments
Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
2
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
Y
Ying Yuan, M.D
W
Weijia Fang, M.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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