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CEA CAR-T cells

Phase 1

Colorectal Cancer | Monoclonal antibody | Oncology |Precision BioSciences, Inc.|Last Updated: Apr 28, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment110

FDA Designations

No designations recorded

Clinical trial landscape

CEA CAR-T cells · 2 trials · 9 indications

Phase 1 2
NCT06010862Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid TumorsGastric Cancer
RECRUITING36 Analytics
NCT05396300A Clinical Study of CEA-targeted CAR-T in the Treatment of CEA-positive Advanced Malignant Solid TumorsColorectal Cancer
RECRUITING110 Analytics
PHASE1RECRUITING
Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors
Gastric CancerUnlock trial analytics
PHASE1RECRUITING
A Clinical Study of CEA-targeted CAR-T in the Treatment of CEA-positive Advanced Malignant Solid Tumors
Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Adverse events after CEA CAR-T cells infusion [Safety and Tolerability]
28 days

Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)

Obtain the maximum tolerated dose of CEA CAR-T cells[Safety and Tolerability]
28 days

Dose-limiting toxicity after cell infusion

Incidence of Adverse events after CEA-CAR-T cells infusion [Safety and Tolerability]
28 days

Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)

Obtain the maximum tolerated dose of CEA-CAR-T cells[Safety and Tolerability]
28 days

Dose-limiting toxicity after cell infusion

Secondary Endpoints

Disease control rate of CAR-T cell preparations in CEA positive advanced malignancies [Effectiveness]
3 months
Objective response rate (ORR) of CEA CAR-T treatment in patients with CD70-positive advanced malignancies[Effectiveness]
3 months
Duration of Response (DOR) of CEA CAR-T treatment in patients with CEA-positive advanced malignancies[Effectiveness]
3 months
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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 1-10x106 cells/kg
intraperitoneal injection of CEA-targeted CAR-TEXPERIMENTALInfusion of CEA-targeted CAR-T cells by dose of 1-10x106 cells/kg
Intraperitoneal infusion of FAST CEA-targeted CAR-TEXPERIMENTALIntraperitoneal infusion of FAST CEA-targeted CAR-T cells by 4 dose levels

Interventions

NameTypeDescription
CEA CAR-T cellsBIOLOGICALAfter lymphodepletion with Fludarabine and Cyclophosphamide,CAR T cells were transfused intravenically
Intraperitoneal infusion of FAST CEA-targeted CAR-TBIOLOGICALIntraperitoneal infusion of FAST CEA-targeted CAR-T (PTC13); Subjects will be treated with Fludarabine and Cyclophosphamide based lymphodepleting chemotherapy before CAR-T 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 old, male or female; 2. Advanced, metastatic or recurrent malignant tumors diagnosed by histology or pathology, mainly colorectal cancer, esophageal cancer, gastric cancer, and pancreatic cancer; 3. After receiving at least second-line standard treatment failure...

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

What is CEA CAR-T cells used for?

CEA CAR-T cells is an investigational chimeric antigen receptor T-cell therapy being studied for the treatment of CEA-positive advanced malignant solid tumors, including gastric cancer and colorectal cancer. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who is developing CEA CAR-T cells?

CEA CAR-T cells is being developed by Precision BioSciences, Inc., a biotechnology company listed on NASDAQ under the ticker symbol DTIL. The therapy is in Phase 1 clinical trials for the treatment of CEA-positive solid tumors.

What phase is CEA CAR-T cells in?

CEA CAR-T cells is in Phase 1 clinical development. It is an investigational therapy and has not received regulatory approval. Two Phase 1 trials are currently recruiting participants to evaluate its safety and efficacy in patients with CEA-positive advanced solid tumors.

What clinical trials is CEA CAR-T cells in?

CEA CAR-T cells is being evaluated in two Phase 1 clinical trials. The first, NCT05396300, is studying the therapy in CEA-positive advanced malignant solid tumors, including colorectal and gastric cancer, with an enrollment of 110 participants. The second, NCT06010862, is investigating it in CEA-positive advanced or metastatic solid tumors, including gastric, colon, and other cancers, with 36 participants.

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

Yes, CEA CAR-T cells is also referred to as CEA-targeted CAR-T in clinical trial documentation. The trials NCT05396300 and NCT06010862 both describe the therapy as CEA-targeted CAR-T, indicating that the names are used interchangeably for the same investigational cell therapy.