OncoMatch/Clinical Trials/NCT06821048
Study of CEA Targeting CAR-T (PTC13) in the Treatment of CEA-Positive Advanced Malignant Solid Tumors
Is NCT06821048 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Intraperitoneal infusion of FAST CEA-targeted CAR-T for colorectal cancer.
Treatment: Intraperitoneal infusion of FAST CEA-targeted CAR-T — This is a phase I clinical study to evaluate the safety and tolerability of FAST targeted chimeric antigen receptor (CAR)-T cells (PTC13) in patients with carcinoembryonic antigen (CEA)-positive advanced malignant solid tumors, and to obtain the maximum tolerated dose of FAST CAR-T (PTC13) and phase II Recommended dose.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Gastric Cancer
Pancreatic Cancer
Tumor Agnostic
Biomarker criteria
Required: CEACAM5 overexpression (distinct membrane staining with a positivity rate of ≥10% by IHC within 3 months; if older, serum CEA >10 µg/L)
Immunohistochemical staining of tumor samples within 3 months confirming CEA positivity (distinct membrane staining with a positivity rate of≥10%); if the immunohistochemical result of the tumor sample is more than 3 months old at the time of screening (distinct membrane staining with a positivity rate of≥10%), the patient's serum CEA must exceed 10µg/L.
Disease stage
Metastatic disease required
advanced, metastatic, or recurrent malignant tumors
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard therapy
Failure of at least second-line standard therapy (due to disease progression or intolerance, such as surgery, chemotherapy, radiotherapy, etc.) or a lack of effective treatment options.
Cannot have received: chemotherapy
Chemotherapy ... within 14 days or at least 5 half-lives (whichever is shorter)
Cannot have received: targeted therapy
targeted therapy ... within 14 days or at least 5 half-lives (whichever is shorter)
Cannot have received: experimental drug treatment
other experimental drug treatments within 14 days or at least 5 half-lives (whichever is shorter)
Lab requirements
Blood counts
WBC>2.0×10^9/L, neutrophils>0.8×10^9/L, lymphocytes>0.5×10^9/L, platelets>50×10^9/L, hemoglobin>90g/L
Kidney function
Serum creatinine≤2.0×ULN
Liver function
ALT and AST ≤3.0×ULN (may be relaxed to≤5.0×ULN if liver tumor infiltration is present); total bilirubin≤2.0×ULN
Cardiac function
Echocardiography indicating a left ventricular ejection fraction≥50%, and no significant abnormalities on electrocardiogram
Blood routine: WBC>2.0×10^9/L, neutrophils>0.8×10^9/L, lymphocytes>0.5×10^9/L, platelets>50×10^9/L, hemoglobin>90g/L; Cardiac function: Echocardiography indicating a left ventricular ejection fraction≥50%, and no significant abnormalities on electrocardiogram; Renal function: Serum creatinine≤2.0×ULN; Liver function: ALT and AST ≤3.0×ULN (may be relaxed to≤5.0×ULN if liver tumor infiltration is present); Total bilirubin≤2.0×ULN; Oxygen saturation>92% without supplemental oxygen.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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