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 (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT06821048 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy, targeted therapy, experimental drug treatment disqualifies patients from enrollment.
Does this trial require CEACAM5?
Yes, CEACAM5 overexpression is a required biomarker for enrollment.
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