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Claudin-6 CAR T cells

Claudin-6 is largely silent in adult tissue and re-expressed on some solid tumours. That pattern makes it a candidate target for engineered T cells that would otherwise have too little healthy-tissue margin.

  • RegistryNCT04503278
  • PhasePhase 1/2
  • ConditionCLDN6+ solid tumours
  • SponsorBioNTech
How a claudin-6 CAR T cell works

The drug

What is being tested.

Chimeric antigen receptor T cells are T cells given a synthetic receptor so they can recognise a surface protein without MHC. The hard problem in solid tumours is choosing a protein the cancer has and healthy adult tissue does not.

Claudin-6 is an oncofetal tight-junction protein: present in development, mostly off in adult organs, and re-expressed on subsets of testicular, ovarian, and other solid tumours. The CAR is directed at that protein.

Some protocols add a CLDN6-encoding mRNA vaccine after infusion. The idea is to present the same antigen in the lymph node and keep the engineered cells expanded — a CAR plus a boost, rather than a CAR alone.

The study

How the trial runs.

BNT211 is a first-in-human program of CLDN6-directed CAR T cells, with or without a CLDN6 mRNA vaccine, in patients whose tumours express claudin-6. Early cohorts map dose, lymphodepletion, and whether the vaccine arm changes persistence.

Live record on ClinicalTrials.gov →

Eligibility

Who the study is looking for.

  • Solid tumour with CLDN6 expression, as defined by the protocol assay
  • Adequate organ function for lymphodepletion and cell therapy
  • No contraindication to CAR T manufacturing or infusion

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.

How these trials work: what Phase 1 actually is · common questions Not clinical evidence.

Not sure whether you would qualify?

Would this trial apply to me?