Biliary Tract CancerEarly Phase 1NCT06937567
CDH17 CAR-T Therapy in Advanced Malignant Solid Tumors
A Early Phase 1 study testing CDH17 CAR-T and FAST LACO-Stim CDH17 CAR-T in people with Biliary Tract Cancer and Colorectal Carcinoma, run by Zhejiang University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Biliary Tract Cancer, Colorectal Carcinoma, Gastric Cancer, Metastatic
- What is being tested?
- CDH17 CAR-T and FAST LACO-Stim CDH17 CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 26 Dec 2024to 30 May 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
Hangyu Zhang
About this study
Official title: Exploratory Study on the Safety and Preliminary Efficacy of UCLH80-1 Cells in Patients With CDH17-Positive Advanced Malignant Solid Tumors
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.
Read the detailed description
The trial progresses through sequential Phase Ia (dose-finding) and Phase Ib (dose-expansion) stages. Phase Ia cessation triggers include either confirmation of Recommended Phase II Dose (RP2D) or investigator-verified favorable therapeutic index at any dose level. Post-Phase Ia completion, protocol amendment submission to the Institutional Review Board precedes Phase Ib initiation, featuring multi-cohort expansion (n=9-18/cohort) across specified malignancies: colorectal adenocarcinoma (CRC), gastric carcinoma (GC), high-grade serous ovarian carcinoma (HGSOC), breast cancer (BC), non-small cell lung cancer (NSCLC), SCLC, metastatic castration-resistant prostate cancer (mCRPC), clear cell renal cell carcinoma (ccRCC), and cervical squamous cell carcinoma (CSCC), etc.
This is a single-center, open-label, dose-escalation study consisting of two distinct treatment cohorts for patients with CDH17-positive advanced malignant solid tumors: Cohort 1 (CDH17 CART): A dose-escalating (3+3 design) study with 3 dose levels: 1.0×10^6, 3.0×10^6, and 6.0×10^6 CAR+ cells/kg. Cohort 2 (FAST LACO-Stim CDH17 CART): A dose-escalating (3+3 design) study with 2 dose levels: 3.0×10^4, and 1.0×10^5 CAR+ cells/kg. During dose escalation, the investigator may adjust the dose level as appropriate based on the accumulated human safety and tolerability, pharmacokinetic, and pharmacodynamic data.
The final sample size will depend on the occurrence of dose-limiting toxicities (DLTs), the number of dose escalation groups before observing DLTs, and the maximum tolerated dose (MTD). The observation period for dose-limiting toxicity (DLT) is set from the start of cell infusion to 4 weeks after the completion of cell infusion (D0 to D28).
- Conditions
- Biliary Tract Cancer, Colorectal Carcinoma, Gastric Cancer, Metastatic, Pancreatic Adenocarcinoma (Ductal Adenocarcinoma), Multiple Cancer
- Being tested
- CDH17 CAR-T, FAST LACO-Stim CDH17 CAR-T
- Keywords
- CAR-T, CDH17
- Medical subject headings
- Biliary Tract Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDH17 CAR-TBiological
The initial dose of cell therapy in this clinical study was set at 1.0×106/Kg and the maximum dose was set at 6.0×106/Kg.
FAST LACO-Stim CDH17 CAR-TBiological
The initial dose of LACO-Stim CDH17 CAR-T cell therapy in this clinical study was set at 3.0×104/kg and the maximum dose was set at 1.0×105/kg. Subjects will be treated with Fludarabine and Cyclophosphamide based lymphodepleting chemotherapy before CAR-T cell infusion.
| Study group | Role | What they receive |
|---|---|---|
| CDH17 CAR-T treatment arm | Experimental | In this study, patients with advanced malignant solid tumors with positive CDH17 expression will be enrolled in a traditional "3+3 design" dose climb test.
The initial dose of cell therapy in this clinical study was set at 1.0×10^6/Kg and the maximum dose was set at 6.0×10^6/Kg. Receives: Biological: CDH17 CAR-T |
| FAST LACO-Stim CDH17 CAR-T treatment arm | Experimental | Intravenous infusion of FAST LACO-Stim CDH17 CAR-T cells by 2 dose levels.In this study, patients with advanced malignant solid tumors with positive CDH17 expression will be enrolled to receive the upgraded FAST LACO-Stim CDH17 CAR-T cells. The dose escalation will follow a modified "3+3 design". The initial dose of cell therapy was set at 3.0×10^4/kg, and the maximum dose was set at 1.0×10^5/kg. During dose escalation, the investigator may adjust the dose level as appropriate based on the accumulated human safety and tolerability, pharmacokinetic, and pharmacodynamic data. Receives: Biological: FAST LACO-Stim CDH17 CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of UCLH801 cells in patients with advanced malignant solid tumors with positive expression of CDH17
The number and severity of dose-limiting toxicity (DLT) events and all adverse events occurring in subjects following the infusion of UCLH801 cells; The determination of the recommended Phase II dose (RP2D). Periodic analysis may be conducted during the dose esclation stage, including subgroup analysis, such as CDH17 expression strength, prior therapy lines and tumor burden.
Measured: 28 days after the CAR-T cells infusion
Secondary outcomes (7)
Evaluate the preliminary response rate of UCLH801 cells in patients with advanced malignant solid tumors expressing CDH17.
Efficacy: Evaluated based on objective response rate (ORR) and disease control rate (DCR)
Measured: 64 days
Evaluate the pharmacodynamic (PD) characteristics of UCLH801 cells in subjects
Pharmacodynamics: Cytokine levels in blood/serum at various time points, including IL-2, IL-6, IL-8, IL-10, TNF-α, and IFN-γ.
Measured: 28 days
Evaluate the concentration of anti-UCLH801 cell antibodies in serum
The production of anti-UCLH801 cell antibodies in serum
Measured: 28 days
Evaluate the preliminary response rate of UCLH801 cells in patients with advanced malignant solid tumors expressing CDH17.
Evaluate the PFS and OS of all enrolled patients
Measured: 2 years
Evaluate the peak plasma concentration (Cmax) of UCLH801 cells
After cell infusion, the peak concentration (Cmax), time to reach peak concentration (Tmax)
Measured: 28 days
Evaluate the long-time area under the curve (AUC) of UCLH801 cells.
Pharmacokinetics: After cell infusion, the area under the curve (AUC) from 0 to 90 days (AUC0-90) of UCLH801 cells in peripheral blood.
Measured: 90 days
Evaluate the area under the plasma concentration versus time curve (AUC) of UCLH801 cells
After cell infusion, evaluate the area under the curve (AUC) from 0 to 28 days (AUC0-28)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start26 Dec 2024
- Primary completion30 Mar 2028 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- UTC Therapeutics Inc.
- Responsible party
- Principal investigator, Weijia Fang, MD, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937567
- Sponsor's protocol ID
- UCLH801-II
- Status last verified
- May 2026
- First submitted
- 24 Dec 2024
- Last updated
- 26 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on the Safety and Preliminary Efficacy of UCLH80-1 Cells in Patients With CDH17-Positive Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT06937567
- Acronym / sponsor ID
- UCLH801-II
- Conditions
- Biliary Tract Cancer, Colorectal Carcinoma, Gastric Cancer, Metastatic, Pancreatic Adenocarcinoma (Ductal Adenocarcinoma), Multiple Cancer
- Keywords
- CAR-T, CDH17
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- UTC Therapeutics Inc.
- Study start
- 26 Dec 2024 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The trial progresses through sequential Phase Ia (dose-finding) and Phase Ib (dose-expansion) stages. Phase Ia cessation triggers include either confirmation of Recommended Phase II Dose (RP2D) or investigator-verified favorable therapeutic index at any dose level. Post-Phase Ia completion, protocol amendment submission to the Institutional Review Board precedes Phase Ib initiation, featuring multi-cohort expansion (n=9-18/cohort) across specified malignancies: colorectal adenocarcinoma (CRC), gastric carcinoma (GC), high-grade serous ovarian carcinoma (HGSOC), breast cancer (BC), non-small cell lung cancer (NSCLC), SCLC, metastatic castration-resistant prostate cancer (mCRPC), clear cell renal cell carcinoma (ccRCC), and cervical squamous cell carcinoma (CSCC), etc.
This is a single-center, open-label, dose-escalation study consisting of two distinct treatment cohorts for patients with CDH17-positive advanced malignant solid tumors: Cohort 1 (CDH17 CART): A dose-escalating (3+3 design) study with 3 dose levels: 1.0×10^6, 3.0×10^6, and 6.0×10^6 CAR+ cells/kg. Cohort 2 (FAST LACO-Stim CDH17 CART): A dose-escalating (3+3 design) study with 2 dose levels: 3.0×10^4, and 1.0×10^5 CAR+ cells/kg. During dose escalation, the investigator may adjust the dose level as appropriate based on the accumulated human safety and tolerability, pharmacokinetic, and pharmacodynamic data.
The final sample size will depend on the occurrence of dose-limiting toxicities (DLTs), the number of dose escalation groups before observing DLTs, and the maximum tolerated dose (MTD). The observation period for dose-limiting toxicity (DLT) is set from the start of cell infusion to 4 weeks after the completion of cell infusion (D0 to D28).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CDH17 CAR-T treatment arm | Experimental | Biological: CDH17 CAR-TIn this study, patients with advanced malignant solid tumors with positive CDH17 expression will be enrolled in a traditional "3+3 design" dose climb test. The initial dose of cell therapy in this clinical study was set at 1.0×10^6/Kg and the maximum dose was set at 6.0×10^6/Kg. |
| FAST LACO-Stim CDH17 CAR-T treatment arm | Experimental | Biological: FAST LACO-Stim CDH17 CAR-TIntravenous infusion of FAST LACO-Stim CDH17 CAR-T cells by 2 dose levels.In this study, patients with advanced malignant solid tumors with positive CDH17 expression will be enrolled to receive the upgraded FAST LACO-Stim CDH17 CAR-T cells. The dose escalation will follow a modified "3+3 design". The initial dose of cell therapy was set at 3.0×10^4/kg, and the maximum dose was set at 1.0×10^5/kg. During dose escalation, the investigator may adjust the dose level as appropriate based on the accumulated human safety and tolerability, pharmacokinetic, and pharmacodynamic data. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDH17 CAR-TThe initial dose of cell therapy in this clinical study was set at 1.0×106/Kg and the maximum dose was set at 6.0×106/Kg. | Biological | CDH17 CAR-T treatment arm |
| FAST LACO-Stim CDH17 CAR-TThe initial dose of LACO-Stim CDH17 CAR-T cell therapy in this clinical study was set at 3.0×104/kg and the maximum dose was set at 1.0×105/kg. Subjects will be treated with Fludarabine and Cyclophosphamide based lymphodepleting chemotherapy before CAR-T cell infusion. | Biological | FAST LACO-Stim CDH17 CAR-T treatment arm |
Primary outcome
The safety of UCLH801 cells in patients with advanced malignant solid tumors with positive expression of CDH17
Time frame: 28 days after the CAR-T cells infusion
The number and severity of dose-limiting toxicity (DLT) events and all adverse events occurring in subjects following the infusion of UCLH801 cells; The determination of the recommended Phase II dose (RP2D). Periodic analysis may be conducted during the dose esclation stage, including subgroup analysis, such as CDH17 expression strength, prior therapy lines and tumor burden.
7 secondary outcomes
Evaluate the preliminary response rate of UCLH801 cells in patients with advanced malignant solid tumors expressing CDH17.
Time frame: 64 days
Evaluate the pharmacodynamic (PD) characteristics of UCLH801 cells in subjects
Time frame: 28 days
Evaluate the concentration of anti-UCLH801 cell antibodies in serum
Time frame: 28 days
Evaluate the preliminary response rate of UCLH801 cells in patients with advanced malignant solid tumors expressing CDH17.
Time frame: 2 years
Evaluate the peak plasma concentration (Cmax) of UCLH801 cells
Time frame: 28 days
Evaluate the long-time area under the curve (AUC) of UCLH801 cells.
Time frame: 90 days
Evaluate the area under the plasma concentration versus time curve (AUC) of UCLH801 cells
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CDH17 CAR-T and FAST LACO-Stim CDH17 CAR-T in people with Biliary Tract Cancer and Colorectal Carcinoma, run by Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weijia Fang, Doctor (+86-0571-87235147, weijiafang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety of UCLH801 cells in patients with advanced malignant solid tumors with positive expression of CDH17 (time frame: 28 days after the CAR-T cells infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.