OncoMatch/Clinical Trials/NCT06946615
Exploratory Clinical Study of Claudin18.2-Targeted CAR-DC and CAR-T Therapy in Advanced Colorectal Cancer
Is NCT06946615 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including Claudin18.2-targeted CAR-T Cells and Claudin18.2-targeted CAR-DCs for colorectal neoplasia.
Treatment: Claudin18.2-targeted CAR-T Cells · Claudin18.2-targeted CAR-DCs — This is an open-label, single-arm clinical study designed to evaluate the safety and preliminary efficacy of Claudin18.2-targeted CAR-DC combined with CAR-T cell therapy in patients with advanced colorectal cancer.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Colorectal Cancer
Biomarker criteria
Required: CLDN18 overexpression (positive by IHC)
Claudin18.2 expression must be confirmed as positive in tumor tissue by immunohistochemistry (IHC)
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: fluoropyrimidine
Must have received: irinotecan
Must have received: oxaliplatin
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L, platelet count ≥ 75 × 10^9/L, and hemoglobin ≥ 9 g/dL. No blood transfusions, G-CSF, TPO, or EPO allowed within 14 days prior to hematology testing.
Kidney function
Serum creatinine ≤ 1.5 × ULN; or if > 1.5 × ULN, creatinine clearance (CrCl) ≥ 60 mL/min as calculated by the Cockcroft-Gault formula.
Liver function
Total bilirubin (TBIL) < 1.5 × ULN; AST and ALT < 2.5 × ULN. For patients with Gilbert's syndrome, TBIL < 2 × ULN. For patients with liver metastases, AST and ALT must be < 5 × ULN.
Adequate organ function, defined as follows: * Hematologic function: Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L, platelet count ≥ 75 × 10^9/L, and hemoglobin ≥ 9 g/dL. No blood transfusions, granulocyte colony-stimulating factor (G-CSF), thrombopoietin (TPO), or erythropoietin (EPO) allowed within 14 days prior to hematology testing. * Hepatic function: Total bilirubin (TBIL) < 1.5 × upper limit of normal (ULN); AST and ALT < 2.5 × ULN. For patients with Gilbert's syndrome, TBIL < 2 × ULN. For patients with liver metastases, AST and ALT must be < 5 × ULN. * Renal function: Serum creatinine ≤ 1.5 × ULN; or if > 1.5 × ULN, creatinine clearance (CrCl) ≥ 60 mL/min as calculated by the Cockcroft-Gault formula. * Coagulation function: Prothrombin time (PT) and activated partial thromboplastin time (APTT) < 1.5 × ULN; international normalized ratio (INR) < 1.5 or within the therapeutic range if on anticoagulation therapy.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06946615 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received fluoropyrimidine and irinotecan.
Does this trial require CLDN18?
Yes, CLDN18 overexpression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages