Recent Updates
Recently added Catalysts

BNT211

Phase 1

Solid Tumor | Monoclonal antibody | Oncology |BioNTech SE|Last Updated: Jun 18, 2026

Target and mechanism

ModalityMonoclonal antibody

Also known as CLDN6 CAR-T

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLED
Total Trials1
Total Enrollment214

FDA Designations

No designations recorded

Clinical trial landscape

BNT211 · 1 trial · 1 indication

Phase 1 1
NCT04503278A Clinical Study of the Safety and Effectiveness of an Investigational Cell Therapy Given With and Without an Investigational RNA-based Vaccine in Patients With Organ TumorsSolid Tumor
ACTIVE NOT_RECRUITING214 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Clinical Study of the Safety and Effectiveness of an Investigational Cell Therapy Given With and Without an Investigational RNA-based Vaccine in Patients With Organ Tumors
Solid Tumor
NCT04503278214
Unlock trial analytics

Study Endpoints

Primary Endpoints

Occurrence of treatment-emergent adverse events (TEAEs) including ≥ Grade 3, serious, fatal TEAEs by relationship
up to 25 months
Occurrence of dose reduction and discontinuation of investigational medicinal product (IMP) due to TEAEs
up to 25 months
Occurrence of dose-limiting toxicity (DLT) during the DLT evaluation period
Day 1 to day 28

Secondary Endpoints

Change from baseline in the levels and kinetics of soluble immune factors measured by cytokine multiplex assay
Baseline up to 25 months
Objective response rate
up to 25 months
Disease control rate
up to 25 months
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelFACTORIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1 - CLDN6 CAR-TEXPERIMENTALDose escalation in lymphodepleted patients until the MTD and/or RP2D.
Part 2 Vaccine-modulated - CLDN6 uRNA-LPX/CLDN6 modRNA-LPXEXPERIMENTALDose escalation until the MTD and/or RP2D.

Interventions

NameTypeDescription
CLDN6 CAR-TBIOLOGICALadministered as an intravenous (i.v.) infusion.
CLDN6 uRNA-LPX/CLDN6 modRNA-LPXBIOLOGICALadministered as an i.v. injection at protocol-specified intervals.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Each patient enrolled in the trial must have CLDN6-positive tumor regardless of tumor histology defined as ≥ 50% of tumor cells expressing CLDN6 protein at an intensity of ≥2+ using a semi-quantitative immunohistochemistry assay in a central laboratory for specific detection o...

Countries:AustraliaGermanyNetherlandsSweden
Unlock Eligibility Criteria

Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumor")

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
Unlock Competitive Intelligence

Recent Changes (Last 90 Days)

MEDIUMJun 18, 2026NCT04503278Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 18, 2026NCT04503278Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 18, 2026NCT04503278Status: RECRUITING → ACTIVE_NOT_RECRUITING