OncoMatch/Clinical Trials/NCT06013111
An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti-CEA-CAR-T Cells Injection in Patients With CEA+ Locally Advanced and/or Metastatic Solid Tumors
Is NCT06013111 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Intravenous infusion anti-CEA-CAR-T cell for carcinoma.
Treatment: Intravenous infusion anti-CEA-CAR-T cell — This is a single-center, open-label clinical study of anti-CEA-CAR-T cells for CEA+ patients with locally advanced and/or metastatic solid tumors. In this study, a single-dose regimen was designed, and the investigator had the discretion to decide whether the patient received more than once CAR T-cell therapy.This study intends to include CEA+ patients with locally advanced and/or metastatic solid tumors.They will take the anti-CEA-CAR-T cell transfusion after a screening period, mononuclear cell (PBMC) collection, bridging therapy if necessary, and lymphocyte clearance pretreatment period.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: CEACAM5 high expression (intensity of 2+ and above on the area ≥50%) (2+ and above on ≥50% of tumor area)
Cytoplasmic and/or membranous high CEA expression in tumor tissue is required (expression intensity of 2+ and above on the area ≥50%)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: CAR-T cell therapy
Previously using any CAR-T cell products or other genetically modified T cell therapies
Cannot have received: antibody therapy
Antibody therapy within 4 weeks before apheresis and preconditioning
Cannot have received: anti-PD-1 therapy
Anti-PD-1/PD-L1 monoclonal antibody therapy within 4 weeks before apheresis and preconditioning
Cannot have received: anti-PD-L1 therapy
Anti-PD-1/PD-L1 monoclonal antibody therapy within 4 weeks before apheresis and preconditioning
Cannot have received: immunostimulation or immunosuppressive therapy
Immunostimulation or immunosuppressive therapy within 28 days prior to apheresis
Cannot have received: radiation therapy
Exception: except limited local palliative radiotherapy
Radiotherapy within 28 days prior to apheresis, except limited local palliative radiotherapy
Cannot have received: major surgery
Exception: except exploratory laparotomy or laparoscopy exploration
Received any major surgery within 4 weeks before apheresis (except exploratory laparotomy or laparoscopy exploration) or severe trauma
Lab requirements
Blood counts
Neutrophil ≥ 1.0×10^9/L; Hemoglobin≥ 80g/L; Platelet ≥ 75×10^9/L; Lymphocytes ≥ 0.5×10^9/L; no performed blood transfusion or received cell growth factor within 7 days before screening hematological evaluation
Kidney function
creatinine ≤1.5× ULN or endogenous creatinine clearance ≥50 mL/min
Liver function
serum total bilirubin ≤1.5× ULN (excluding Gilbert's syndrome); AST and ALT≤2.5×ULN; (AST and ALT ≤5×ULN with liver metastasis)
Cardiac function
LVEF ≥ 50%
Adequate hematological function ; have no performed blood transfusion or received cell growth factor within 7 days before screening hematological evaluation: Neutrophil ≥ 1.0×10^9/L; Hemoglobin≥ 80g/L; Platelet ≥ 75×10^9/L; Lymphocytes ≥ 0.5×10^9/L. Adequate liver function: serum total bilirubin ≤1.5× ULN (excluding Gilbert's syndrome); AST and ALT≤2.5×ULN；( AST and ALT ≤5×ULN with liver metastasis). Adequate renal function: creatinine ≤1.5× ULN or endogenous creatinine clearance ≥50 mL/min. LVEF ≥ 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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