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OncoMatch/Clinical Trials/NCT07179692

CEA-Targeted CAR-T Therapy in CEA-Positive Advanced Solid Tumors

Is NCT07179692 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including CEA-targeted CAR-T cells and CEA-targeted CAR-T cells for lung cancer.

Phase 1RecruitingChongqing Precision Biotech Co., LtdNCT07179692Data as of May 2026

Treatment: CEA-targeted CAR-T cells · CEA-targeted CAR-T cells · CEA-targeted CAR-T cellsThis study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CEA-targeted CAR-T cell preparations, and to preliminarily observe the study drug in CEA-positive advanced malignant tumors. The pharmacokinetic characteristics of CAR-T cell preparations for the treatment of patients with CEA-positive advanced malignancies were obtained and the recommended dose and infusion schedule.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Gastric Cancer

Colorectal Cancer

Esophageal Carcinoma

Pancreatic Cancer

Biomarker criteria

Required: CEACAM5 overexpression (immunohistochemical positivity (clear membrane staining, positivity rate ≥ 10%) within past 3 months OR if older, serum CEA > 10 µg/L)

Immunohistochemical staining of tumor samples showing CEA positivity (clear membrane staining, positivity rate ≥ 10%) within the past 3 months; if the immunohistochemical result is older than 3 months (clear membrane staining, positivity rate ≥ 10%), serum CEA must exceed 10 µg/L

Disease stage

Metastatic disease required

advanced, metastatic, or recurrent malignant tumors

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 2 prior lines

Must have received: standard treatment

Failure of at least second-line standard treatment (disease progression or intolerance, such as surgery, chemotherapy, radiotherapy, etc.) or lack of effective treatment options

Cannot have received: chemotherapy

Exception: within 14 days or at least 5 half-lives (whichever is shorter) prior to screening

Received the following anti-tumor treatments within 14 days or at least 5 half-lives (whichever is shorter) prior to screening: chemotherapy, targeted therapy, or other experimental drug treatments

Cannot have received: targeted therapy

Exception: within 14 days or at least 5 half-lives (whichever is shorter) prior to screening

Received the following anti-tumor treatments within 14 days or at least 5 half-lives (whichever is shorter) prior to screening: chemotherapy, targeted therapy, or other experimental drug treatments

Cannot have received: experimental drug treatments

Exception: within 14 days or at least 5 half-lives (whichever is shorter) prior to screening

Received the following anti-tumor treatments within 14 days or at least 5 half-lives (whichever is shorter) prior to screening: chemotherapy, targeted therapy, or other experimental drug treatments

Lab requirements

Blood counts

White blood cells > 2.0 × 10^9/L, neutrophils > 0.8 × 10^9/L, lymphocytes > 0.5 × 10^9/L, platelets > 50 × 10^9/L, hemoglobin > 90 g/L

Kidney function

Serum creatinine ≤ 2.0 × ULN

Liver function

ALT and AST ≤ 3.0 × ULN (can be relaxed to ≤ 5.0 × ULN for patients with liver tumor infiltration); Total bilirubin ≤ 2.0 × ULN

Cardiac function

Echocardiogram shows ejection fraction ≥ 50%, ECG shows no significant abnormalities

Hematology: White blood cells > 2.0 × 10^9/L, neutrophils > 0.8 × 10^9/L, lymphocytes > 0.5 × 10^9/L, platelets > 50 × 10^9/L, hemoglobin > 90 g/L; Cardiac function: Echocardiogram shows ejection fraction ≥ 50%, ECG shows no significant abnormalities; Renal function: Serum creatinine ≤ 2.0 × ULN; Liver function: ALT and AST ≤ 3.0 × ULN (can be relaxed to ≤ 5.0 × ULN for patients with liver tumor infiltration); 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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