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

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.

Trial Details

NCT ID
NCT07250386
Phase
PHASE1
Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • CEA-targeted CAR-T (Intravenous)
  • CEA-targeted CAR-T (Intrapleural)
Locations (sample)
  • Hangzhou, Zhejiang, China|30.29365,120.16142

Key Eligibility Criteria

  • 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, t…
  • CEA positivity confirmed by immunohistochemistry (IHC) in tumor samples within 3 months of screening (clear membrane staining, with positivity rate…

For full eligibility, visit ClinicalTrials.gov.

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