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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
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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment1
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05349890Personalized TCR-T: Study of Adoptively Transferred T-cell Receptor Gene-engineered T Cells (TCR-T)PHASE1 ACTIVE NOT_RECRUITING 1Apr 3, 2023Apr 15, 2028Apr 24, 20261 United States
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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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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT05349890studyFirstPostDate: changed