Search the database for deliberate release of GM medicinal products

Displaying 1 - 16 of 16

EU record number	Title	Company / Sponsor	Treated organism	Genetic modification
B/BE/20/BVW3	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	Transgene	Humans	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).
B/BE/18/BVW5	A Phase 1b/2a study to assess the safety and tolerability of GM Lactococcus lactis in subjects with Type 1 Diabetes Mellitus	Intrexon T1D Partners, LLC	Humans	Biologically contained strain of Lactococcus lactis, genetically modified to secrete human interleukin-10 and proinsulin
B/BE/18/BVW1	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	Transgene	Humans	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.
bb2121-MM-001	A phase II, multicenter study to determine the efficacy and safety of bb2121 in subjects with relapsed and refractory multiple myeloma	Celgene	Humans	BCMA02 (human B cell maturation antigen)-CAR
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	Humans	Modified cells expressing Hemoglobin F (HbF)
Only notified under the "contained use" procedure. Dossier submitted on 24/04/2018.	A Phase 2a Randomized, Double-blind, Placebo-controlled rial to Assess the safety, Immunogenicity, and Efficacy of the Recombinant MVA-BN-RSV Vaccine against Respiratory Syncytial Virus Infection in the Virus Challenge Model in Healthy Adult Volunteers	Bavarian Nordic A/S	Humans	Vaccinia virus Ankara strain expression glycoproteins of different RSV strain (MVA-BN)
Only notified under the "contained use" procedure. Dossier submitted on 24/04/2018.	A phase 2, single-arm, multi-cohort, multi-center trial to determine the efficacy and safety of jcar017 in adult subjects with aggressive b-cell non-hodgkin lymphoma	Celgene	Humans	EGFRt en chimeric antigen receptor against CD19
B/BE/17/BVW1	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)	Transgene	Humans	Sequences coding for human mucine 1 (MUC1) antigen and interleukin-2 (IL2)
68284528MMY2001	A phase III, multicenter, randomized, open-label study to compare the efficacy and safety of bb2121 versus standard triplet regimens in subjects with relapsed and refractory multiple myeloma (RRMM) (KarMMa-3)	Celgene	Humans	BCMA02 (human B cell maturation antigen) -Chimeric antigen receptor
Only notified under the "contained use" procedure. Dossier submitted on 23/11/2016.	A phase 2, open-label, multi-cohort, single-arm, multi-center trial to determine the safety, feasibility, and efficacy of JCAR015 in adult subjects with B-cell acute lymphoblastic leukemia	Celgene	Humans	Chimeric antigen receptor against CD19
B/BE/12/BVW1	A multi-center, randomized, double-blind, placebo-controlled Phase I/II trial to compare the safety, tolerability and immunogenicity of the therapeutic THV01 vaccination of HIV-1 clade B infected patients under highly antiretroviral therapy	TheraVectys	Humans	genes encoding the epitopes of the HIV-1 Gag, Pol and Nef proteins
B/BE/11/BVW1	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)	Transgene	Humans	sequences coding for human mucine 1 (MUC1) antigen and interleukin-2 (IL2)
B/BE/03/B3	Phase I multicentre study of TG1024 (Adenovirus interleukin 2) in patients with metastatic melanoma or other advanced solid tumor cancers	Transgene S.A.	Humans	gene coding for human interleukin 2
B/BE/02/B7	Phase II study evaluating the clinical efficacy of TG4010 (MVA-MUC1-IL2) in patients with metastatic Renal Cell Carcinoma (RCC)	Transgene S.A.	Humans	sequences coding for the human MUC-1 antigen and IL-2
B/BE/01/B7	Specific immunotherapy against MUC-1 antigen - Study TG4010.04 : "Phase II study with TG4010(MVA-MUC-1-IL-2) in patients with metastatic breast cancer", Study TG4010.05 : "Phase II study with TG 4010 in patients with non small cell lung cancer"	Transgene S.A.	Humans	sequences coding for the human MUC-1 antigen and IL-2
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	Transgene	Humans	Muc-1 and Interleukine 2 (IL-2)