Actively Recruiting
Exploratory Study on the Safety and Preliminary Efficacy of UCLH801 Cells in Patients With CDH17-Positive Advanced Malignant Solid Tumors
Led by Zhejiang University · Updated on 2026-05-26
36
Participants Needed
1
Research Sites
8 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
Researchers are studying UCLH801 cells, a CAR-T cell therapy designed to target CDH17-positive advanced malignant solid tumors. This includes cancers such as colorectal, gastric, pancreatic, biliary tract, neuroendocrine, ovarian, and lung cancers. The main goal is to evaluate the safety and tolerability of these cells, while also assessing their early effects on tumors, how they act in the body, and any immune responses they might cause. The trial is divided into Phase Ia (dose-finding) and Phase Ib (dose-expansion) stages. During Phase Ia, patients receive escalating doses of UCLH801 cells, either CDH17 CAR-T cells or FAST LACO-Stim CDH17 CAR-T cells, with doses adjusted based on safety and biological responses. The study uses a "3+3 design" for dose escalation, with intravenous infusions given at specific dose levels. Prior to receiving FAST LACO-Stim CDH17 CAR-T cells, patients undergo lymphodepleting chemotherapy. Phase Ib involves expanding groups of patients with various cancer types at confirmed doses. Participants will be closely monitored for side effects and changes in laboratory tests from the start of infusion through 28 days after. Researchers will measure the safety of the treatment, early tumor responses, pharmacokinetics, pharmacodynamics, and immune reactions for up to two years. The study includes assessments like tumor measurements, blood tests for cell concentrations and antibodies, and survival expectations. Participation lasts through treatment and follow-up periods to gather comprehensive safety and response data.
CONDITIONS
Brief 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, or biliary tract cancers
- Failed or intolerant to standard treatments, or no effective options available
- At least one measurable tumor lesion as defined by RECIST v1.1
- Tumor tissue available from biopsy or new specimen
- Tumor confirmed CDH17-positive by immunohistochemistry or immunocytochemistry
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival of 3 months or more
- Adequate organ function including blood counts, liver, kidney, heart, and lung function as specified
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective contraception during study and for 1 year after final infusion
- Willingness to sign informed consent and comply with study procedures
You will not qualify if you...
- Pregnant or breastfeeding women
- Positive hepatitis B or C with detectable virus levels
- Positive HIV or syphilis antibody tests
- Unresolved non-blood toxicities from prior treatments above grade 1 (except hair loss or neuropathy)
- Prior allogeneic tissue or organ transplant requiring immunosuppression
- Previous CDH17 CAR-T therapy outside this study
- Major surgery within 4 weeks without full recovery or serious unresolved trauma
- Known central nervous system metastases, except asymptomatic or stable cases
- Severe active infections or lung diseases needing systemic corticosteroids within 6 months
- Symptomatic heart failure, severe valve disease, prolonged QTc on ECG
- Uncontrolled high blood pressure
- Stroke within 6 months
- Severe autoimmune diseases needing immunosuppressive treatment
- Any form of primary or secondary immunodeficiency
- Risk of organ perforation or bleeding
- Severe allergic reactions to study drugs or components
- Live vaccines within 4 weeks before consent
- Participation in another clinical trial within 4 weeks
- History of other cancers within 5 years except treated non-melanoma skin or in situ cancers
- Neuropsychiatric disorders or conditions unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks from the start of cell infusion
Participants receive escalating doses of CDH17 CAR-T cell therapy or FAST LACO-Stim CDH17 CAR-T cell therapy after lymphodepleting chemotherapy. The treatment dose and schedule may be adjusted based on safety and tolerability.
1 infusion visit with close monitoring through Day 28
Duration - Up to 2 years
Participants are monitored for safety, pharmacodynamics, and preliminary efficacy after treatment. This includes assessments up to 2 years for response evaluation and up to 90 days for pharmacokinetic analysis.
Multiple visits including assessments at 28 days, 64 days, 90 days, and long-term follow-up visits
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
H
Hangyu Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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