OncoMatch/Clinical Trials/NCT06937567
CDH17 CAR-T Therapy in Advanced Malignant Solid Tumors
Is NCT06937567 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies CDH17 CAR-T for biliary tract cancer.
Treatment: CDH17 CAR-T — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Colorectal Cancer
Gastric Cancer
Pancreatic Cancer
Biomarker criteria
Required: CDH17 overexpression (positive by IHC or ICC)
Tumor specimens must be confirmed as CDH17-positive by immunohistochemistry (IHC) or immunocytochemistry (ICC) staining.
Disease stage
Metastatic disease required
Gastric Cancer, Metastatic
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard treatments
Patients must have failed standard treatments, be intolerant to standard treatments, or lack effective treatment options.
Cannot have received: CDH17 CAR-T therapy
Exception: except those who received CAR-T infusion within this study
Patients who have previously received CDH17 CAR-T therapy, except those who received CAR-T infusion within this study.
Cannot have received: allogeneic tissue or organ transplant
Exception: except for transplants not requiring immunosuppression (e.g., corneal or hair transplantation)
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).
Lab requirements
Blood counts
ANC ≥ 1.5 × 10⁹/L; ALC ≥ 0.5 × 10⁹/L; HGB ≥ 80 g/L; PLT ≥ 75 × 10⁹/L
Kidney function
serum creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 60 mL/min (Cockcroft-Gault)
Liver function
AST/ALT ≤ 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)
Cardiac function
LVEF ≥ 50% (echocardiography); ECG QTc ≤ 450 ms or ≤ 480 ms with bundle branch block; no symptomatic CHF (NYHA II-IV), severe aortic/mitral stenosis
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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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