NCT04503278

Phase I/IIa, First-in-human, Open-label, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety and Preliminary Efficacy of CLDN6 CAR-T With or Without CLDN6 RNA-LPX in Patients With CLDN6-positive Relapsed or Refractory Advanced Solid Tumors

Study Summary

This is a Phase I, FIH, open-label, multi-site, dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of claudin 6 (CLDN6) chimeric antigen receptor T cells (CAR-T) with or without CLDN6 ribonucleic acid lipoplexes (RNA-LPX) in patients with CLDN6-positive relapsed or refractory advanced solid tumors.

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Interventions

CLDN6 CAR-TBIOLOGICAL
administered as an intravenous (i.v.) infusion.
CLDN6 uRNA-LPX/CLDN6 modRNA-LPXBIOLOGICAL
administered as an i.v. injection at protocol-specified intervals.

Study Locations

FacilityCityStateCountry
Peter MacCallum Cancer CentreMelbourneVictoriaAustralia
Charité - Universitätsmedizin Berlin - Campus Benjamin FranklinBerlinGermany
Universitätsklinikum Köln AÖR-Centrum für Integrierte Onkologie (CIO)-Studienzentrum der Klinik I für Innere Medizin (CTU Cologne)CologneGermany
Universitätsklinikum Erlangen - Hämatologie & Intrinsische Onkologie - Medizinische Klinik 5ErlangenGermany
Universitätsklinikum Hamburg Eppendorf - II Medizinische Klinik und PoliklinikHamburgGermany
Medizinische Hochschule Hannover - Klinik für Hämatologie, Hämostaseologie, Onkologie und StammzelltransplantationHanoverGermany
Nationales Centrum für Tumorerkrankungen (NCT) HeidelbergHeidelbergGermany
Universitätsmedizin Mainz - III Medizinische Klinik und PoliklinikMainzGermany
Universitätsklinikum Regensburg - Klinik und Poliklinik für Innere Medizin IIIRegensburgGermany
He Nederlands Kanker Instituut (The Netherlands Cancer Institute) - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL)AmsterdamNetherlands
Erasmus MC - Universitair Medisch Centrum - Medical oncologyRotterdamNetherlands
Karolinska Comprehensive Cancer Center Cancerstudieenheten Huddinge Karolinska UniversitetssjukhusetStockholmSweden

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026