A Study of CEA-Targeted CAR-T Therapy in Patients With CEA-Positive Advanced Solid Tumors

NCT07250386 | Recruiting Phase 1

• 1 other identifier: 2025-0883
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This 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.

Conditions

NSCLC (Advanced Non-small Cell Lung Cancer); Breast Cancer

Outcome Measures

Primary Outcomes (2)

• To evaluate the safety of CAR-T cell preparations in the treatment of CEA-positive advanced malignancies [Safety and Tolerability]

  Incidence of adverse events during the study, evaluated per the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) criteria

  From infusion through Month 3

• Obtained the recommended dose and infusion regimen of CAR-T cells for the treatment of patients with CEA-positive advanced malignancies [Safety and Tolerability]

  Dose-limiting toxicity after CEA CAR-T cell infusion

  From infusion through Month 3

Secondary Outcomes (9)

• Assessing disease control(DCR) rates of CAR-T cell preparations in CEA-positive advanced malignancies [Effectiveness]

  From infusion through Month 3

• Objective response rate (ORR) of CEA CAR-T treatment in patients with CEA-positive advanced malignancies [Effectiveness]

  2 years

• Duration of Response (DOR) of CEA CAR-T treatment in patients with CEA-positive advanced malignancies [Effectiveness]

  2 years

• Progress-free survival(PFS) of CEA CAR-T treatment in patients with CEA-positive advanced malignancies [Effectiveness]

  2 years

• Overall survival(OS)of CEA CAR-T treatment in patients with CEA-positive advanced malignancies [Effectiveness]

  2 years

Other Outcomes (4)

• Change in Residual Tumor Cells after CEA CAR-T Therapy

  2 years

• Change in CEA Expression after CEA CAR-T Therapy

  2 years

• Change in Tumor-Infiltrating Immune Cells after CEA CAR-T Therapy

  2 years

Study Arms (2)

Intravenous of CEA-targeted CAR-T

EXPERIMENTAL

Infusion of CEA-targeted CAR-T cells by dose of 2-6x10\^5 cells/kg

Biological: CEA-targeted CAR-T (Intravenous)

Intrapleural infusion of CEA-targeted CAR-T

EXPERIMENTAL

Infusion of CEA-targeted CAR-T cells by dose of 2-6x10\^5 cells/kg

Biological: CEA-targeted CAR-T (Intrapleural)

Interventions

CEA-targeted CAR-T (Intravenous) BIOLOGICAL

Administration method: intravenous infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion

Intravenous of CEA-targeted CAR-T

CEA-targeted CAR-T (Intrapleural) BIOLOGICAL

Administration method: intrapleural infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion

Intrapleural infusion of CEA-targeted CAR-T

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years or older, of any gender.
• Histologically or cytologically confirmed advanced, metastatic, or recurrent solid tumors, including non-small cell lung cancer and breast cancer.
• Disease progression or intolerance after at least second-line standard therapy, including but not limited to surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
• CEA positivity confirmed by immunohistochemistry (IHC) in tumor samples within 3 months of screening (clear membrane staining, with positivity rate ≥10%). If the IHC result is more than 3 months old, serum CEA must be above 10 ng/mL.
• At least one evaluable lesion according to RECIST 1.1, with a longest diameter of ≥10 mm for non-lymph node lesions and a shortest diameter of ≥15 mm for lymph node lesions. Malignant pleural effusion is acceptable for the chest infusion subgroup.
• For patients with malignant pleural effusion, accurate volume assessment of pleural effusion by imaging (CT or MRI) and cytological or thoracoscopic biopsy confirmation of malignant pleural effusion.
• ECOG performance status of 0-2.
• Life expectancy of 12 weeks or more.
• No serious psychiatric disorders.
• The following organ function criteria should be met unless otherwise specified:
• Hematology: White blood cell count \>2.0×10\^9/L, neutrophils \>1.0×10\^9/L, lymphocytes \>0.5×10\^9/L, platelets \>50×10\^9/L, hemoglobin \>80 g/L.
• Cardiac function: Echocardiography showing ejection fraction ≥50%, with no significant abnormalities on ECG.
• Renal function: Serum creatinine ≤2.0×ULN.
• Liver function: ALT and AST ≤3.0×ULN (≤5.0×ULN for those with liver tumor infiltration).
• Total bilirubin ≤2.0×ULN.

You may not qualify if:

• Clinical symptoms of CNS metastasis or meningeal metastasis at screening, or other evidence suggesting that CNS metastasis or meningeal metastasis is uncontrolled, as determined by the investigator.
• Participation in other clinical trials within 4 weeks prior to screening.
• Receipt of a live attenuated vaccine within 4 weeks prior to screening.
• Receipt of chemotherapy, targeted therapy, or other experimental drugs within 14 days or at least 5 half-lives (whichever is shorter) prior to screening.
• Active or uncontrolled infection requiring systemic treatment.
• Tumor compression of the trachea or major blood vessels, with significant risk as assessed by the investigator.
• History of any of the following cardiac diseases:
• New York Heart Association (NYHA) Class III or IV congestive heart failure.
• Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months prior to screening.
• Clinically significant ventricular arrhythmias or unexplained syncope (except those caused by vasovagal or dehydration).
• History of severe non-ischemic cardiomyopathy.
• Active autoimmune disease or other conditions requiring long-term immunosuppressive therapy.
• History of or concurrent untreated malignancies within 3 years, except for basal cell carcinoma or in situ cervical cancer.
• Positive for HBsAg or HBcAb with HBV DNA levels above the normal range, HCV antibody positive with HCV RNA levels above the normal range, HIV antibody positive, or positive for syphilis.
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Chongqing Precision Biotech Co., Ltd: collaborator

Study Sites (1)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310017, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Breast Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Fuming Qiu, PhD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

• Junqiang Fan, PhD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fuming Qiu, PhD

CONTACT

+86 13858005908; qiufuming@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two experimental cohorts by infusion route - intravenous (IV) and intrathoracic (IT). Each cohort conducts sequential dose escalation using an enhanced 3+3 design (3 dose levels; 3-6 participants per level depending on DLTs), followed by optional dose expansion at 1-2 selected dose levels. The two route cohorts may run in parallel operationally, but enrollment within each cohort proceeds sequentially per the dose-escalation scheme.

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: November 26, 2025
• Study Start: October 13, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: November 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)