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CEA-targeted CAR-T

Phase 1

NSCLC (Advanced Non-small Cell Lung Cancer) | Monoclonal antibody | Oncology |Precision BioSciences, Inc.|Last Updated: Nov 26, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07250386A Study of CEA-Targeted CAR-T Therapy in Patients With CEA-Positive Advanced Solid TumorsPHASE1 RECRUITING 48Oct 13, 2025Sep 30, 2028Nov 26, 20251 China
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Study Endpoints
Primary Endpoints
To evaluate the safety of CAR-T cell preparations in the treatment of CEA-positive advanced malignancies [Safety and Tolerability]
From infusion through Month 3

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

Obtained the recommended dose and infusion regimen of CAR-T cells for the treatment of patients with CEA-positive advanced malignancies [Safety and Tolerability]
From infusion through Month 3

Dose-limiting toxicity after CEA CAR-T cell infusion

Secondary Endpoints
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
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Intravenous of CEA-targeted CAR-TEXPERIMENTALInfusion of CEA-targeted CAR-T cells by dose of 2-6x10\^5 cells/kg
Intrapleural infusion of CEA-targeted CAR-TEXPERIMENTALInfusion of CEA-targeted CAR-T cells by dose of 2-6x10\^5 cells/kg
Interventions
NameTypeDescription
CEA-targeted CAR-T (Intravenous)BIOLOGICALAdministration method: intravenous infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion
CEA-targeted CAR-T (Intrapleural)BIOLOGICALAdministration method: intrapleural infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Aged 18 years or older, of any gender. 2. Histologically or cytologically confirmed advanced, metastatic, or recurrent solid tumors, including non-small cell lung cancer and breast cancer. 3. Disease progression or intolerance after at least second-line standard therapy, incl...

Countries:China
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07250386studyFirstPostDate: changed