Actively Recruiting
Clinical Study on the Safety and Preliminary Efficacy of CDH17/GUCY2C CAR-T in the Treatment of Patients With Advanced Colorectal Cancer
Led by Guangzhou Bio-gene Technology Co., Ltd · Updated on 2025-09-03
20
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single-arm, single-center investigator-initiated trial (IIT) designed to evaluate the safety and preliminary efficacy of CDH17/GUCY2C CAR-T cell therapy in patients with advanced colorectal cancer, as well as to assess its pharmacodynamic (PD) and pharmacokinetic (PK) profiles.
CONDITIONS
Official Title
Clinical Study on the Safety and Preliminary Efficacy of CDH17/GUCY2C CAR-T in the Treatment of Patients With Advanced Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Have advanced colorectal cancer with failed standard treatment, intolerable toxicity, or are unsuitable/unwilling for standard treatment
- Can provide immunohistochemical test results within the past 2 years showing positive CDH17/GUCY2C expression in tumor tissue
- Have at least one measurable extracranial lesion according to RECIST 1.1 criteria
- Have an ECOG performance status score of 0-1 and expected survival of at least 3 months
- Have recovered from previous treatment toxicities with CTCAE grade less than 2
- Have no significant blood cell dysfunction and adequate organ function
- Are able to meet requirements for blood collection or have acceptable stored blood cell products
You will not qualify if you...
- Have or had other cancers within the past 5 years
- Have brain metastases
- Have a history or current central nervous system disorders
- Have tumors invading or indistinct from major blood vessels on imaging
- Received cytotoxic drugs or other treatments affecting lymphocyte expansion within 14 days or 5 half-lives prior to blood collection
- Have other viral infections
- Have history of severe allergies
- Have severe heart disease
- Have severe liver, kidney dysfunction, or disorders of consciousness
- Have active autoimmune or inflammatory diseases
- Have lung conditions such as pulmonary fibrosis, interstitial pneumonia, or severe lung impairment
- Have undergone or are awaiting organ transplantation
- Have infections requiring intravenous antibiotics or uncontrolled infections
- Received live virus vaccines within 4 weeks prior to screening
- Are alcoholics or have substance abuse history
- Are pregnant or breastfeeding
- Participated in other drug clinical trials within 30 days
- Have contraindications to study procedures or other medical conditions posing unacceptable risks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Dongguan Taixin Hospital
Dongguan, Guangdong, China, 523125
Actively Recruiting
Research Team
X
Xiaohu Hao, Ph.D. degree
CONTACT
C
Chunfu Li, Ph.D. degree
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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