Actively Recruiting
CDH17 CAR-T Therapy in Advanced Malignant Solid Tumors
Led by Zhejiang University · Updated on 2025-04-22
18
Participants Needed
1
Research Sites
109 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang University
Lead Sponsor
U
UTC Therapeutics Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The investigational product used in this study, UCLH801 cells, is a CAR-T cell therapy specifically targeting CDH17. The proposed indication includes CDH17-positive advanced solid tumors, such as but not limited to colorectal cancer, gastric cancer, pancreatic cancer, biliary tract tumors, neuroendocrine tumors, ovarian cancer, and lung cancer. The primary objective of this study is to evaluate the safety and tolerability of UCLH801 cells in patients with CDH17-positive advanced malignant solid tumors. The secondary objectives include assessing the preliminary efficacy of UCLH801 cells, their pharmacokinetics and pharmacodynamics in the body, and their immunogenicity. This study aims to observe how the infusion of UCLH801 cells affects patients 's body, including any discomfort or changes in laboratory test results. Additionally, it will evaluate whether UCLH801 cells have any effect on tumor. Furthermore, the study will investigate how UCLH801 cells are metabolized; the mechanisms through which they exert their effects, and how to develops any immune response or rejection against UCLH801 cells.
CONDITIONS
Official Title
CDH17 CAR-T Therapy in Advanced Malignant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathologically confirmed malignant solid tumors including colorectal, gastric, pancreatic, and biliary tract cancers.
- Patients who have failed standard treatments, are intolerant to them, or have no effective treatment options.
- At least one measurable tumor lesion according to RECIST v1.1 criteria.
- Availability of tumor tissue from prior biopsy or new specimen.
- Tumor confirmed as CDH17-positive by immunohistochemistry or immunocytochemistry.
- ECOG performance status of 0 or 1.
- Expected survival time of at least 3 months.
- Adequate organ function including specified blood counts, liver, renal, cardiac, and pulmonary functions.
- Negative pregnancy test for females of childbearing potential.
- Agreement to use effective contraception during the study and for one year after final cell infusion.
- Willingness to sign informed consent and comply with study procedures.
You will not qualify if you...
- Pregnant or breastfeeding women.
- Positive hepatitis B surface antigen or core antibody with detectable HBV DNA.
- Positive hepatitis C antibody with detectable HCV RNA.
- Positive HIV antibody.
- Positive syphilis antibody tests.
- Unresolved non-hematological toxicities above CTCAE grade 1 from prior treatments.
- Prior allogeneic tissue or organ transplant requiring immunosuppression.
- Prior CDH17 CAR-T therapy outside this study.
- Major surgery within 4 weeks before consent without full recovery or unresolved serious trauma.
- Known active central nervous system metastases except stable or asymptomatic brain metastases.
- Severe active infections or pulmonary diseases requiring systemic corticosteroids within 6 months.
- Symptomatic congestive heart failure or severe valvular heart disease.
- ECG abnormalities including QTc prolongation.
- Uncontrolled hypertension.
- Recent cerebrovascular accident within 6 months.
- Active severe autoimmune diseases requiring immunosuppressives.
- Primary or secondary immunodeficiency.
- Risk of organ perforation or bleeding.
- Severe hypersensitivity reactions to study drugs.
- Live attenuated vaccines within 4 weeks before consent.
- Participation in another clinical study within 4 weeks before consent.
- History of other malignancies in past 5 years except treated skin or in situ cancers.
- Neuropsychiatric disorders or conditions unsuitable for study participation.
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
W
Weijia Fang, Doctor
CONTACT
H
Hangyu Zhang
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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