Actively Recruiting
Anti-CDH17 CAR-T Cell Injection in Patients With CDH17-positive Advanced Malignant Solid Tumors
Led by Shanghai Pudong Hospital · Updated on 2024-07-15
17
Participants Needed
1
Research Sites
98 weeks
Total Duration
On this page
Sponsors
S
Shanghai Pudong Hospital
Lead Sponsor
U
UTC Therapeutics Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single-arm, open-label, exploratory clinical study to evaluate the safety and preliminary efficacy of Anti-CDH17 CAR-T cell injection in patients with CDH17-positive advanced malignant solid tumors.
CONDITIONS
Official Title
Anti-CDH17 CAR-T Cell Injection in Patients With CDH17-positive Advanced Malignant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years, any gender
- Histologically confirmed malignant solid tumors resistant or relapsed after standard therapy, including colorectal, gastric, pancreatic, and biliary tract cancers
- At least one measurable tumor lesion according to RECIST v1.1
- CDH17 positivity confirmed by immunohistochemistry or immunocytochemistry in tumor samples
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of 3 months or more
- Adequate organ function as required by the study protocol
- Female participants of childbearing potential must have a negative pregnancy test
- Participants of childbearing potential must agree to use effective contraception from screening until at least 1 year after infusion
- Ability to understand the study and provide informed consent, and willingness to comply with study procedures and follow-up
You will not qualify if you...
- Received systemic chemotherapy, monoclonal antibodies, immunotherapy within 4 weeks or 5 half-lives before consent
- Received systemic glucocorticoids (≥10 mg prednisone or equivalent) or immunosuppressive therapy within 2 weeks before consent
- Received biologic antitumor therapy or targeted small-molecule inhibitors within 1 week or 5 half-lives before consent
- Received Chinese herbal or patent medicine with anti-tumor effects within 1 week before consent
- Pregnant or breastfeeding women
- Positive for hepatitis B surface antigen or active hepatitis B or C infection, HIV, or syphilis
- Toxicities from prior therapies not recovered to grade 1 (except hair loss and peripheral sensory nerve disorders)
- History of allogeneic tissue or organ transplantation requiring immunosuppression
- Prior anti-CDH17 CAR-T cell therapy
- Major surgery or severe trauma within 4 weeks before consent or planned major surgery within 12 weeks after cell therapy
- Known active central nervous system metastases unless asymptomatic and stable without treatment for ≥4 weeks
- Significant uncontrolled systemic diseases impairing treatment tolerance or increasing risk, including severe infections, organ dysfunction, heart failure, arrhythmias, recent coronary events, uncontrolled hypertension, recent stroke, active autoimmune diseases requiring immunosuppression, immunodeficiency, or bleeding risks
- History of severe allergic reactions to study drugs or ingredients
- Received attenuated vaccines within 4 weeks before consent
- Participation in other clinical trials within 4 weeks before consent
- History of another malignancy within 5 years except certain adequately treated cancers
- History of neuropsychiatric diseases such as epilepsy, schizophrenia, dementia, or substance addiction
- Any other conditions deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Pudong hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
Z
Zhiguo Long
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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