Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
18 participants
INTERVENTIONAL
2024-12-26
2027-01-31
Brief Summary
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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.
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Detailed Description
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This study has 3 dose levels and follows a "3+3 design," with an estimated enrollment of 9 to 18 subjects. 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). Considering the possibility of cell production preparation failure or other reasons (such as rapid disease progression during cell preparation) leading to subjects ultimately being unable to receive cell infusion therapy, the number of participants in the cell collection and preparation process may be greater than the planned number of cases.
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).
The starting dose of cell infusion therapy in this clinical study is set at 1.0×10\^6/Kg, and the maximum dose is set at 6.0×10\^6/Kg.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CDH17 CAR-T treatment arm
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 1.0×106/Kg and the maximum dose was set at 6.0×106/Kg.
CDH17 CAR-T
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.
Interventions
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CDH17 CAR-T
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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UTC Therapeutics Inc.
INDUSTRY
Zhejiang University
OTHER
Responsible Party
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Weijia Fang, MD
Chief doctor
Locations
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The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Hangyu Zhang
Role: primary
Other Identifiers
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UCLH801-II
Identifier Type: -
Identifier Source: org_study_id
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