CAR-T therapy targeting CDH17 for advanced solid tumors
Exploratory Study on the Safety and Preliminary Efficacy of UCLH80-1 Cells in Patients With CDH17-Positive Advanced Malignant Solid Tumors
This study is testing a new CAR-T cell therapy aimed at treating advanced solid tumors that have a specific marker called CDH17 in patients who have run out of other treatment options.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Zhejiang University Academic / other |
| Drugs / interventions | CAR-T, chemotherapy, immunotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06937567 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and tolerability of UCLH801 cells, a CAR-T cell therapy specifically designed to target CDH17 in patients with advanced malignant solid tumors. The study includes a dose-finding Phase Ia and a dose-expansion Phase Ib, focusing on various cancers such as colorectal, gastric, and pancreatic cancers. Participants must have CDH17-positive tumors and have exhausted standard treatment options. The trial will assess the effects of the therapy on tumor response and monitor any adverse effects during the treatment process.
Who should consider this trial
Good fit: Ideal candidates are patients with CDH17-positive advanced solid tumors who have failed or are intolerant to standard treatments.
Not a fit: Patients with tumors that are not CDH17-positive or those who have not exhausted standard treatment options may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with advanced solid tumors that currently have limited effective therapies.
How similar studies have performed: While CAR-T therapies have shown success in hematological malignancies, this approach targeting solid tumors is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histopathologically confirmed malignant solid tumors, including but not limited to colorectal cancer, gastric cancer, pancreatic cancer, and biliary tract tumors. * Patients must have failed standard treatments, be intolerant to standard treatments, or lack effective treatment options. * At least one measurable lesion as defined by RECIST v1.1 criteria. * Tumor tissue must be available either from prior tumor biopsy or by providing new tumor specimens. * Tumor specimens must be confirmed as CDH17-positive by immunohistochemistry (IHC) or immunocytochemistry (ICC) staining. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Expected survival time ≥ 3 months. * Appropriate organ function: hematological: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Absolute lymphocyte count (ALC) ≥ 0.5 × 10⁹/L. Hemoglobin (HGB) ≥ 80 g/L; Platelet count (PLT) ≥ 75 × 10⁹/L. Liver Function: aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 3.0 × ULN (≤ 5.0 × ULN for patients with primary liver tumors or liver metastases); total bilirubin ≤ 1.5 × ULN (≤ 3.0 × ULN for patients with primary liver tumors or liver metastases; ≤ 3 × ULN for Gilbert's syndrome with direct bilirubin ≤ 1.5 × ULN). Coagulation: international normalized ratio (INR) ≤ 1.5 × ULN (unless on therapeutic anticoagulants); activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (unless on therapeutic anticoagulants). Renal Function: serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance rate ≥ 60 mL/min (based on Cockcroft-Gault formula). Cardiac Function: left ventricular ejection fraction (LVEF) ≥ 50% (confirmed by echocardiography). Pulmonary Function: resting oxygen saturation (SpO₂) \> 92% without supplemental oxygen. * Female participants of childbearing potential must have a negative pregnancy test. * Female participants of childbearing potential or male participants with partners of childbearing potential must agree to use effective contraception during the study and for 1 year after the final cell infusion. * Willingness to sign the informed consent form, demonstrating understanding of the study and agreement to comply with study procedures. Exclusion Criteria: * Women who are pregnant or breastfeeding. * Positive hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) with peripheral HBV DNA levels above the lower limit of detection. * Positive hepatitis C virus (HCV) antibody with peripheral HCV RNA levels above the lower limit of detection. * Positive HIV antibody. * Positive syphilis-specific and non-specific antibody tests. * Non-hematological toxicity from prior treatment (surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) has not resolved to ≤ CTCAE grade 1 (except for hair loss and peripheral sensory neuropathy). * Prior allogeneic tissue or organ transplant (including bone marrow, stem cell, liver, kidney, etc.), except for transplants not requiring immunosuppression (e.g., corneal or hair transplantation). * Patients who have previously received CDH17 CAR-T therapy, except those who received CAR-T infusion within this study. * Underwent major surgery within 4 weeks prior to signing informed consent and has not fully recovered, or has a history of serious unresolved trauma. * Known central nervous system (CNS) metastases (with exceptions for asymptomatic brain metastases or stable clinical symptoms). * Severe active infections or pulmonary diseases requiring systemic corticosteroid treatment within 6 months prior to signing informed consent. * Symptomatic congestive heart failure (NYHA class II-IV), severe aortic stenosis, or symptomatic mitral stenosis. * ECG showing QTc \> 450 ms or QTc \> 480 ms with bundle branch block. * Uncontrolled hypertension (SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg). * Cerebrovascular accidents within 6 months prior to signing informed consent. * Active, chronic, or recurrent severe autoimmune diseases requiring immunosuppressive treatment (with exceptions). * Any form of primary or secondary immunodeficiency. * Risk of organ perforation or bleeding as judged by the investigator. * Severe systemic hypersensitivity reactions to study drugs/components. - Received live attenuated vaccines within 4 weeks prior to signing informed consent. * Participated in another clinical study within 4 weeks prior to signing informed consent. * History of another malignancy within the past 5 years, except for adequately treated non-melanoma skin cancer or in situ cancers. * Diagnosed with neuropsychiatric disorders or any condition deemed by the investigator as unsuitable for participation.
Where this trial is running
Hangzhou, Zhejiang
- The First Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Weijia Fang, Doctor
- Email: weijiafang@zju.edu.cn
- Phone: +86-0571-87235147
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.