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TCR-transduced T cells

Phase 1

Malignant Epithelial Neoplasms | Monoclonal antibody | Oncology |Celldex Therapeutics, Inc.|Last Updated: Apr 24, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment1

FDA Designations

No designations recorded

Clinical trial landscape

TCR-transduced T cells · 1 trial · 1 indication

Phase 1 1
NCT05349890Personalized TCR-T: Study of Adoptively Transferred T-cell Receptor Gene-engineered T Cells (TCR-T)Malignant Epithelial Neoplasms
ACTIVE NOT_RECRUITING1 Analytics
PHASE1ACTIVE NOT_RECRUITING
Personalized TCR-T: Study of Adoptively Transferred T-cell Receptor Gene-engineered T Cells (TCR-T)
Malignant Epithelial NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of adverse events
2 years
Severity of adverse events
2 years

Severity of adverse events using CTCAE version 5.0

Secondary Endpoints

Objective response rate
2 years
Duration of response
2 years
Clinical benefit rate
2 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CDX-1140 + TCR-T + PembroEXPERIMENTALPatients will receive CDX-1440, TCR-T, and pembrolizumab.

Interventions

NameTypeDescription
TCR-transduced T cellsBIOLOGICALTSA-reactive TCR-engineered T cells
CDX-1140DRUGRecombinant fully human IgG2κ monoclonal antibody
PembrolizumabDRUGHumanized immunoglobulin G4 (IgG4) monoclonal antibody
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Eligibility Criteria

SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Patients 18 years and older with metastatic or locoregionally advanced epithelial cancers, that are considered incurable. 2. Confirmation by Tran Laboratory of neoantigen-reactive TCR(s) suitable for TCR-gene therapy. 3. Eastern Cooperative Oncology Group (ECOG) performance s...

Countries:United States
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Frequently asked questions about TCR-transduced T cells

What is TCR-transduced T cells used for?

TCR-transduced T cells is an investigational cell therapy being studied for the treatment of malignant epithelial neoplasms, a type of cancer. It is currently in Phase 1 clinical development and has not been approved by the FDA. The therapy is being evaluated in a single active clinical trial in the United States.

Who is developing TCR-transduced T cells?

Celldex Therapeutics, Inc. (NASDAQ: CLDX) is developing TCR-transduced T cells. The company is conducting a Phase 1 clinical trial of this investigational therapy for malignant epithelial neoplasms. The trial is currently active but not recruiting participants.

What phase is TCR-transduced T cells in?

TCR-transduced T cells is in Phase 1 clinical development. It is an investigational therapy, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is designed to study the safety and feasibility of this personalized T-cell receptor gene-engineered T cell therapy.

What clinical trials is TCR-transduced T cells in?

TCR-transduced T cells is being studied in one clinical trial, NCT05349890, titled 'Personalized TCR-T: Study of Adoptively Transferred T-cell Receptor Gene-engineered T Cells (TCR-T)'. This Phase 1 trial is active but not recruiting, with an enrollment of 1 participant, and is being conducted in the United States.

Is TCR-transduced T cells the same as TCR-T?

Yes, TCR-transduced T cells is also referred to as TCR-T, as indicated in the clinical trial title. The therapy involves the adoptive transfer of T cells that have been gene-engineered to express a specific T-cell receptor. This personalized approach is being evaluated for malignant epithelial neoplasms.