Hypoxia-responsive CEA-targeted CAR T cells in CEA-positive solid tumors through intraperitoneal or intravenous infusion: a phase 1 trial.
Yang Gao, Jie Li, Hangyu Zhang...
https://pubmed.ncbi.nlm.nih.gov/41760800Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID05396300
A Phase I Clinical Study of Anti-CEA CAR-T Therapy in the Treatment of CEA-positive Advanced Malignant Solid Tumors
Led by Weijia Fang, MD · Updated on 2026-04-28
110
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
W
Weijia Fang, MD
Lead Sponsor
C
Chongqing Precision Biotech Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying a new type of treatment called CAR-T therapy for patients with advanced malignant solid tumors that test positive for carcinoembryonic antigen (CEA). This phase I clinical trial aims to evaluate the safety and tolerability of CAR-T cells in these patients and to determine the highest dose that can be safely given as well as the recommended dose for future studies. The study focuses mainly on patients with colorectal cancer who have not responded to standard treatments. The trial includes three groups of patients receiving CAR-T cells through different methods: intravenous infusion, intraperitoneal injection, and a specialized intraperitoneal infusion called FAST CAR-T. Each group undergoes a dose-escalation process with increasing levels of CAR-T cells to find the optimal dose. Before receiving CAR-T cells, participants are treated with chemotherapy to prepare their bodies for the therapy. Participants will be closely monitored for adverse events within 28 days after receiving CAR-T cells to assess safety. Researchers will also measure disease control rates, changes in tumor markers, and how the CAR-T cells behave in the body over a one-year period. Assessments include blood tests, imaging of tumors, and evaluations of organ function. The trial will continue until December 2027, with regular follow-ups to gather information on treatment effects and patient health.
CONDITIONS
Brief Title
A Clinical Study of CEA-targeted CAR-T in the Treatment of CEA-positive Advanced Malignant Solid Tumors
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, male or female
- Diagnosed with advanced, metastatic, or recurrent malignant tumors confirmed by histology or pathology, mainly colorectal cancer
- Have received at least second-line standard treatment and experienced treatment failure or intolerance
- Tumor confirmed CEA positive by immunohistochemical staining within 3 months or serum CEA above 10 ug/L if over 3 months
- At least one measurable lesion per RECIST 1.1 criteria
- ECOG performance status score between 0 and 2
- No serious mental disorders
- Adequate vital organ function including blood counts, heart, kidney, liver, and oxygen saturation levels
- Meet standards for apheresis or venous blood collection without contraindications
- Agree to use reliable contraception for one year after CAR-T infusion
- Signed informed consent agreeing to participate in the clinical trial
You will not qualify if you...
- Central nervous system or meningeal metastases with symptoms or uncontrolled condition
- Participation in other clinical studies within one month before screening
- Vaccinated with live attenuated vaccine within four weeks before screening
- Received chemotherapy, targeted therapy, or experimental drugs within 14 days or five half-lives prior to screening
- Active or uncontrollable infections requiring systemic treatment
- Intestinal obstruction, active gastrointestinal bleeding, or history of bleeding within three months
- Previous treatment toxicity not improved to baseline or grade 1 or less except alopecia or neuropathy
- Severe heart diseases including NYHA stage III/IV heart failure, recent myocardial infarction or bypass surgery, significant arrhythmia, or severe cardiomyopathy
- Active autoimmune disease or requiring long-term immunosuppressive therapy
- Other untreated malignant tumors within past three years except certain skin and cervical cancers
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis beyond normal ranges
- Pregnant or breastfeeding women
- Any condition investigator deems unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Dose-escalating treatment period as per cohort design
Participants receive lymphodepleting chemotherapy followed by CAR-T cell infusion via intravenous infusion or intraperitoneal injection depending on cohort assignment.
1 infusion visit plus additional visits for chemotherapy administration
Follow-up
Duration - Up to 1 year
Participants are monitored for safety, tolerability, and effectiveness after CAR-T cell infusion.
Weekly visits for the first 4 weeks, then periodic visits over 1 year
Trial Site Locations
Total: 1 location
1
First affiliated hospital, Zhejiang University
Hangzhou, Zhejiang, China, 310006
Actively Recruiting
Loading map...
Research Team
W
Weijia Fang, M.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Severe refractory colitis after intraperitoneal infusion of CEA-directed CAR T cells in patients with colorectal cancer.
Kexin Ye, Chaohui Yu, Zhe Shen
https://pubmed.ncbi.nlm.nih.gov/39734708