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
Study ID:
BNT211-01
NCT ID:
NCT04503278
EudraCT ID:
2019-004323-20
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
    • Study Drug
  • CLDN6 CAR-T
    • See more
  • CLDN6 uRNA-LPX/CLDN6 modRNA-LPX
    • Phase
    Phase 1
    Type
    Interventional
    Estimated Enrolment
    145
    Estimated Trial Date
    Sep 2020 - Jan 2027

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Female & Male
    Healthy Volunteers
    No

    Trial locations

    Location
    Status
    Location
    Medizinische Hochschule Hannover - Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation
    Hannover, Germany, 30625
    88.1 miles (141.0 km) away from your location
    Status
    Recruiting