Actively Recruiting
Safety and Preliminary Efficacy of Anti-CDH17 CAR-T Cell Therapy in Patients with CDH17-positive Advanced Solid Tumors
Led by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China · Updated on 2025-02-11
30
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
Sponsors
9
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Lead Sponsor
G
Guangzhou Bio-gene Technology Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single-center, open-label, single-arm study to evaluate the safety and preliminary efficacy of anti-CDH17 CAR-T cells in patients with CDH17-positive advanced solid tumors.
CONDITIONS
Official Title
Safety and Preliminary Efficacy of Anti-CDH17 CAR-T Cell Therapy in Patients with CDH17-positive Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Able to understand and voluntarily sign informed consent
- Diagnosed with CDH17-positive advanced solid tumors confirmed by immunohistochemistry
- No standard treatment available, or standard treatment ineffective or unsuitable
- At least one measurable extracranial tumor lesion per RECIST 1.1
- Expected survival of 12 weeks or more
- ECOG performance status of 0 or 1
- Recovered from prior treatment toxicities with CTCAE grade less than 2 unless tumor-related or stable
- Able to establish venous access and no contraindications for apheresis
You will not qualify if you...
- Current or prior other malignancies
- Brain metastases or significant central nervous system disease
- Prior targeted, epigenetic, or investigational therapy within 14 days or 5 half-lives before blood collection
- Positive for HBsAg or HBcAb with detectable HBV DNA, HCV antibody positive, HIV antibody positive, or elevated CMV or EBV DNA
- Positive sputum smear or T-cell test for tuberculosis
- History or evidence of lung diseases such as pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or severe lung impairment
- Severe allergy history
- Severe heart disease or uncontrolled refractory hypertension
- Severe liver or kidney dysfunction or consciousness disorders
- Active autoimmune or inflammatory nervous system diseases
- Uncontrolled infections needing antibiotics
- Received live attenuated vaccine within 4 weeks before screening
- History of alcoholism or drug abuse
- Pregnant or lactating, or plans for fertility within two years after CAR-T infusion
- Any condition judged unsuitable for trial participation by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sanbin Wang
Kunming, Yunnan, China, 650100
Actively Recruiting
Research Team
S
Sanbin Wang, MD
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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