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 Identifier:
BNT211-01
ClinicalTrials.gov Identifier:
EudraCT Identifier:
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
Medical Condition
Study Drug
Phase
Phase 1
Sex
Female & Male
Age
18+
Estimated Trial Date
Sep 2020 - Jan 2027
Protocol summary
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.
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 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
Hannover, Germany, 30625
Status
Recruiting
Location
Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg
Heidelberg, Germany, 69120
Status
Recruiting