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CEA-targeted CAR-T cells

Phase 1

Colorectal Cancer | Monoclonal antibody | Oncology |Precision BioSciences, Inc.|Last Updated: Oct 2, 2025

Success Probability

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

CEA-targeted CAR-T cells · 4 trials · 12 indications

Phase 1 4
NCT07179692CEA-Targeted CAR-T Therapy in CEA-Positive Advanced Solid TumorsLung Cancer
RECRUITING108 Analytics
NCT06126406Clinical Study of CEA Targeting Chimeric Antigen Receptor T Lymphocytes(CAR-T) for CEA Positive Advanced Malignant Solid TumorsGastric Cancer
RECRUITING60 Analytics
NCT06006390CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid TumorsGastric Cancer
RECRUITING60 Analytics
NCT06043466A Clinical Trial Targeting CEA Chimeric Antigen Receptor T (CAR-T) for CEA Positive Advanced Malignant Solid TumorsColorectal Cancer
RECRUITING30 Analytics
PHASE1RECRUITING
CEA-Targeted CAR-T Therapy in CEA-Positive Advanced Solid Tumors
Lung CancerUnlock trial analytics
PHASE1RECRUITING
Clinical Study of CEA Targeting Chimeric Antigen Receptor T Lymphocytes(CAR-T) for CEA Positive Advanced Malignant Solid Tumors
Gastric CancerUnlock trial analytics
PHASE1RECRUITING
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
Gastric CancerUnlock trial analytics
PHASE1RECRUITING
A Clinical Trial Targeting CEA Chimeric Antigen Receptor T (CAR-T) for CEA Positive Advanced Malignant Solid Tumors
Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

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

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]
1 month

Dose-limiting toxicity after CEA CAR-T cell infusion

Incidence of Treatment-associated Adverse Events [Safety and Tolerability]
1 month

The incidence of adverse events after CEA CAR-T cell infusion was assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 5.0)

To determine the dose range and DLT of C-13-60 cells for CEA positive advanced malignant solid tumors [Safety and Tolerability]
1 month

The incidence of adverse events (TEAE) after treatment; Incidence of treatment-related adverse events; Adverse evens of Special Interest (AESI);

To obtain the maximum tolerable dose of C-13-60 cells [Safety and Tolerability]
1month

Incidence and number of dose-limiting toxicity (DLT) cases,Dose-limiting toxicity after CAR-T cell infusion

Secondary Endpoints

Assessing disease control rates of CAR-T cell preparations in CEA-positive advanced malignancies [Effectiveness]
From infusion through Month 3
To evaluate the efficacy of CAR-T cell preparations in CEA-positive advanced malignancies【Effectiveness】
From infusion through Month 3
To characterize the in-vivo cellular kinetics of CAR-T cells【pharmacokinetics】
From infusion through Month 3
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Intravenous of CEA-targeted CAR-TEXPERIMENTALInfusion of CEA-targeted CAR-T cells by dose of 1-15x10\^5 cells/kg
Intrapleural infusion of CEA-targeted CAR-TEXPERIMENTALInfusion of CEA-targeted CAR-T cells by dose of 1-15x10\^5 cells/kg
Intraperitoneal infusion of CEA-targeted CAR-TEXPERIMENTALInfusion of CEA-targeted CAR-T cells by dose of 1-15x10\^5 cells/kg
intraperitoneal injection of CEA-targeted CAR-TEXPERIMENTALInfusion of CEA-targeted CAR-T cells by dose of 1-10x10\^6 cells/kg
Intravenous of CD70-targeted CAR-TEXPERIMENTALInfusion of CEA-targeted CAR-T cells by dose of 1-10x10\^6 cells/kg
intraperitoneal injection of CD70-targeted CAR-TEXPERIMENTALInfusion of CEA-targeted CAR-T cells by dose of 1-10x10\^6 cells/kg

Interventions

NameTypeDescription
CEA-targeted CAR-T cellsBIOLOGICALAdministration method: intravenous infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Age ≥ 18 years, no gender restriction; 2. Histopathologically confirmed diagnosis of advanced, metastatic, or recurrent malignant tumors, primarily including colorectal cancer, esophageal cancer, gastric cancer, pancreatic cancer, lung cancer, and cholangiocarcinoma; 3. Failu...

Countries:China
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Frequently asked questions about CEA-targeted CAR-T cells

What is CEA-targeted CAR-T cells used for?

CEA-targeted CAR-T cells is an investigational cell therapy being studied for CEA-positive advanced solid tumors, including lung cancer, colorectal cancer, and gastric cancer. It is in Phase 1 clinical development for these indications.

What does CEA-targeted CAR-T cells target?

CEA-targeted CAR-T cells targets carcinoembryonic antigen (CEA), a protein expressed on the surface of certain tumor cells. The therapy is designed to recognize and attack CEA-positive cancer cells in patients with advanced solid tumors.

Who is developing CEA-targeted CAR-T cells?

CEA-targeted CAR-T cells is being developed by Precision BioSciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker DTIL. The therapy is currently in Phase 1 clinical trials.

What phase is CEA-targeted CAR-T cells in?

CEA-targeted CAR-T cells is in Phase 1 clinical development. It is an investigational therapy and has not been approved by regulatory authorities. Multiple Phase 1 trials are currently recruiting patients with CEA-positive advanced solid tumors.

What clinical trials is CEA-targeted CAR-T cells in?

CEA-targeted CAR-T cells is being studied in several Phase 1 trials, including NCT06006390, NCT06043466, NCT06126406, and NCT07179692. These trials are recruiting patients with various CEA-positive advanced solid tumors, such as gastric, colorectal, and lung cancers.

Is CEA-targeted CAR-T cells the same as other CAR-T therapies?

CEA-targeted CAR-T cells is a specific chimeric antigen receptor T-cell therapy that targets CEA. It is distinct from CAR-T therapies targeting other antigens, such as CD19 or BCMA, which are used for different cancer types.