Recruiting nowEarly phase 1
What this trial is trying to do
The researchers are testing CAR-T cells—immune cells genetically fitted with a receptor to recognise the CDH17 protein—against CDH17-positive advanced solid tumours. They expect these cells may find and attack tumour cells carrying CDH17, and will first assess how the body tolerates the infusion.
The trial is mainly asking whether this treatment can be given safely; it will also look for early signs of tumour response and measure how long the cells persist and behave in the body. There is no comparison treatment, so it cannot yet show whether it helps people live longer or delays cancer growth better than standard care.
Worth knowing: This is a small, early-phase, single-arm safety study, and it applies only to tumours that test positive for CDH17.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT06937567 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Early phase 1 |
| Design | not randomised, open label |
| Taking part | 36 people (planned) |
| Who can join | aged 18 Years to 70 Years |
| Run by | Zhejiang University |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Biological CDH17 CAR-T
- Biological FAST LACO-Stim CDH17 CAR-T
What it is measuring
The safety of UCLH801 cells in patients with advanced malignant solid tumors with positive expression of CDH17
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Early phase 1. The earliest human testing. The question is how the drug behaves in the body, not yet whether it helps.
How the researchers describe it
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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
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).
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: China.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT06937567, registered by Zhejiang University on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.