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

Sponsor
Chongqing Precision Biotech Co., Ltd
Study ID
NCT07179692
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CEA-targeted CAR-T cells — BIOLOGICAL
    Administration method: intravenous infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion.
  • CEA-targeted CAR-T cells — BIOLOGICAL
    Administration method: intrapleural infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion.
  • CEA-targeted CAR-T cells — BIOLOGICAL
    Administration method: intraperitoneal infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion.

Study Details

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.

Key Dates

First listed
Sep 18, 2025
Start date
Sep 12, 2025
Status verified
Sep 2025
Primary completion
Mar 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
108 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intravenous of CEA-targeted CAR-T
    Infusion of CEA-targeted CAR-T cells by dose of 1-15x10\^5 cells/kg
  • Experimental: Intrapleural infusion of CEA-targeted CAR-T
    Infusion of CEA-targeted CAR-T cells by dose of 1-15x10\^5 cells/kg
  • Experimental: Intraperitoneal infusion of CEA-targeted CAR-T
    Infusion of CEA-targeted CAR-T cells by dose of 1-15x10\^5 cells/kg

Primary Outcome Measure

To evaluate the safety of CAR-T cell preparations in the treatment of CEA-positive advanced malignancies [Safety and Tolerability] [ Time Frame: 1 month ]

Central Contacts

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