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

Trial status:Recruiting
Trial ID:
BNT211-01
NCT ID:
NCT04503278
EudraCT ID:
2019-004323-20
EU Trial (CTIS) Number:
2024-514962-38-00
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech Cell & Gene Therapies GmbH
Recruiting

Trial Details

This is a Phase I, FIH, open-label, multicenter, 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.

Medical Condition
  • Solid Tumors
    • Trial Drug
  • CLDN6 CAR-T
    • See more
  • CLDN6 uRNA-LPX/CLDN6 modRNA-LPX
    • Phase
    Phase 1
    Type
    Interventional
    Estimated Enrolment
    214
    Estimated Trial Date
    Sep 2020 - Jan 2028

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Female & Male
    Healthy Volunteers
    No

    Trial Locations

    Location
    Status
    Location
    Peter MacCallum Cancer Centre
    Melbourne, Victoria, Australia, 3000
    Status
    Recruiting
    Location
    Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin
    Berlin, Germany, 12200
    Status
    Recruiting
    Location
    Universitätsklinikum Köln AÖR-Centrum für Integrierte Onkologie (CIO)-Studienzentrum der Klinik I für Innere Medizin (CTU Cologne)
    Cologne, Germany, 50937
    Status
    Recruiting
    Location
    Universitätsklinikum Erlangen - Hämatologie & Intrinsische Onkologie - Medizinische Klinik 5
    Erlangen, Germany, 91054
    Status
    Recruiting
    Location
    Universitätsklinikum Hamburg Eppendorf - II Medizinische Klinik und Poliklinik
    Hamburg, Germany, 20246
    Status
    Recruiting
    Location
    Medizinische Hochschule Hannover - Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation
    Hanover, Germany, 30625
    Status
    Recruiting
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