Search the database for deliberate release of GM medicinal products
Displaying 1 - 11 of 11
|EU record number
|Company / Sponsor
|A Phase I/II, multicenter study, evaluating the feasibility, safety, and efficacy of point-of-care manufactured 19CP02 in subjects with relapsed/refractory B-cell non-Hodglin lymphoma
|A Phase I/IIa study of intra-tumoral BT-001 (TG6030) administered alone and in combination with pembrolizumab in patients with cutaneous or, subcutaneous lesions or easily injectable lymph nodes of metastatic/advanced solid tumors
|Replicative oncolytic vaccinia virus derived from the Copenhagen strain, genetically modified by inactivation of its thymidine kinase (TK) and ribonucleotide reductase (RR) genes and by addition of genes encoding for the human granulocyte-macrophage colony-stimulating factor (hGM-CSF) cytokine and for a monoclonal antibody targeting the Cytotoxic T-Lymphocyte-Antigen 4 (CTLA-4).
|A randomized, placebo-controlled trial, to evaluate the safety and immunogenicity of the COVID-19 vaccine, a measles vector-based vaccine candidate against COVID-19 in healthy volunteers consisting of an unblinded dose escalation and a blinded treatment p
|Institut Pasteur & Themis Bioscience GmbH
|Recombinant measles virus vaccine strain (Schwarz strain) expressing the Spike glycoprotein 1 from SARS-CoV2
|Only notified under the "contained use" procedure. Dossier submitted on 02/12/2019.
|A multicentre, open-label, single ascending dose, dose-ranging, phase I/Iia study to evaluate the safety and tolerability of an autologous antigen-specific chimeric antigen receptor T regulatory cell therapy (TX200-TR101) in living donor renal transplant
|chimeric antigen receptor specific to the donor HLA A*2
|A Phase I/IIa study of TG6002 (VV TK-RR-FCU1) administered by intravenous (IV) infusions in combination with oral flucytosine (5-FC) in patients with advanced gastro-intestinal (GI) tumors
|Engineered replicative oncolytic vaccinia virus (VV) derived from the Copenhagen strain. It contains three genetic modifications: 1) deletion of the viral thymidine kinase (TK) gene, 2) deletion of the viral ribonucleotide reductase (RR) gene and 3) insertion of the chimeric yeast FCU1 suicide gene in the TK locus.
|Only notified under the "contained use" procedure. Dossier submitted on 20/08/2018.
|A Phase I/II study of the safety and efficacy of a single dose of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells in subjects with severe sickle disease
|CRISPR Therapeutic AG
|Modified cells expressing Hemoglobin F (HbF)
|Only notified under the "contained use" procedure. Dossier submitted on 21/02/2018.
|Efficacy and safety of bilateral intravitreal injection of GS010: a randomized, double-masked, placebo-controlled trial in subjects affected with G11778A ND4 leber hereditary optic neuropathy for up to one year.
|human wild-type MT-NDA (mitochondrial NADH Dehydrogenase 4)
|A phase II study evaluating the efficacy and the safety of first-line chemotherapy combined with TG4010 and nivolumab in patients with advanced non-squamous Non-Small-Cell Lung Cancer (NSCLC)
|Sequences coding for human mucine 1 (MUC1) antigen and interleukin-2 (IL2)
|Only notified under the "contained use" procedure. Dossier submitted on 20/08/2015.
|A single arm Phase I/II study of the safety and efficacy of gene-modified WT1 TCR therapy in patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
|Catapult Cell Therapy
|Expression of the Wilms' tumour antigen 1 (WT1)- specific T cell receptor (TCR)
|A Phase IIb/III randomized, double-blind, placebo-controlled study comparing first-line therapy with or without TG4010 immunotherapy product in patients with stage IV non-small cell lung cancer (NSCLC)
|sequences coding for human mucine 1 (MUC1) antigen and interleukin-2 (IL2)
|Only notified under the "contained use" procedure. Dossier submitted on 04/06/1998.
|Phase II randomized study of immunotherapy of advanced breast cancer by repeated intramuscular injection of a recombinant vaccinia virus containing sequences coding for human MUC-1 and interleukin-2 (TG1031) comparing two doses levels
|Muc-1 and Interleukine 2 (IL-2)