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CLDN6 CAR-T + CLDN6 RNA-LPX

Development stage
Unknown
Lead developer
BioNTech
Modality
CAR-T Cells → Engineered T Cells → Adoptive Cell Transfer → Cell Therapies, RNA Therapeutics → Nucleic Acid Therapeutics, Lipid-based Nanoparticles → Nanoparticles → Drug Delivery Systems
Administration
Intravenous
01

Overview

CLDN6 CAR-T + CLDN6 RNA-LPX is an investigational combination immunotherapy specifically targeting the oncofetal antigen **Claudin 6 (CLDN6)**, which is re-expressed in various solid tumors but absent from healthy adult tissues. The therapy consists of CLDN6-specific **chimeric antigen receptor T cells (CAR-T cells)**, designed using a second-generation CAR construct with fusion of a CLDN6-specific scFv, CD8α hinge/transmembrane region, and 4-1BB/CD3ζ signaling domains, combined with an **RNA-lipoplex vaccine (CARVac)** that encodes CLDN6 to locally amplify and sustain CAR-T cell expansion and persistence in vivo by stimulating antigen presenting cells. This innovative approach is intended to enhance therapeutic efficacy, especially in **solid tumors** where CAR-T cell persistence and expansion are major challenges. The therapy is being evaluated primarily in relapsed/refractory CLDN6-positive solid tumors, especially germ cell tumors and epithelial ovarian cancers. Initial clinical activity and safety data are encouraging, with evidence of disease control and objective responses, particularly in **germ cell tumors (GCTs)** and **epithelial ovarian carcinoma (EOC)**[1][2][3]. The developers are optimizing automated manufacturing processes for future pivotal trials.

Other names
Claudin 6 CAR-T cell plus CLDN6 RNA vaccineClaudin6 CAR-T cell plus CLDN6 RNA vaccineClaudin-6 CAR-T cell plus CLDN6 RNA vaccineCLDN6-targeted CAR-T cells with RNA-lipoplex vaccineCLDN-6-targeted CAR-T cells with RNA-lipoplex vaccineCLDN 6-targeted CAR-T cells with RNA-lipoplex vaccine
02

Targets

CLDN6 (Claudin-6)

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