A Clinical Study to Evaluate the Safety and Efficacy of CEA-Targeted Chimeric Antigen Receptor T (CAR-T) Cells in Patients With CEA-Positive Advanced Malignant Solid Tumors

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.

‣ Oxygen saturation \>92% without supplemental oxygen.

⁃ Eligible for single or venous blood collection with no contraindications to cell collection.

⁃ Consent to use a reliable and effective method of contraception for 1 year after CAR-T cell infusion (excluding the rhythm method).

⁃ The participant or their authorized guardian agrees to participate in the clinical trial and signs the informed consent form (ICF), indicating an understanding of the trial's purpose and procedures.

Locations
Other Locations
China
The Second Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Fuming Qiu, PhD
qiufuming@zju.edu.cn
+86 13858005908
Time Frame
Start Date: 2025-10-13
Estimated Completion Date: 2028-09-30
Participants
Target number of participants: 48
Treatments
Experimental: Intravenous of CEA-targeted CAR-T
Infusion of CEA-targeted CAR-T cells by dose of 2-6x10\^5 cells/kg
Experimental: Intrapleural infusion of CEA-targeted CAR-T
Infusion of CEA-targeted CAR-T cells by dose of 2-6x10\^5 cells/kg
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators: Chongqing Precision Biotech Co., Ltd

This content was sourced from clinicaltrials.gov