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 (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06013111 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CAR-T cell therapy, antibody therapy, anti-PD-1 therapy disqualifies patients from enrollment.
Does this trial require CEACAM5?
Yes, CEACAM5 high expression (intensity of 2+ and above on the area ≥50%) 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 qualify