Search the database for deliberate release of GM medicinal products

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EU record number	Title	Company / Sponsor	Treated organism	Genetic modification
B/BE/23/BVW2	A Phase 2b, Randomized, Double-masked, Multicenter, Dose-ranging, Sham-controlled Clinical Trial to Evaluate Intravitreal JNJ-81201887(AAVCAGsCD59) Compared to Sham Procedure for the Treatment of Geographic Atrophy (GA) Secondary to Age-related Macular De	Janssen-Cilag International NV	Humans	Non-replicating recombinant vector derived from adeno-associated virus AAV2 carrying the soluble human CD59 gene
B/BE/22/BVW4	A Phase I/II, Multicenter, Open-Label Study of Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors	Nouscom Srl	Humans	The study involves two GMOs: (i) A replication-incompetent adenovirus (GAd20 with deletions of the viral E1, E3 and E4 coding regions) isolated from a gorilla and encoding the FSP neoantigens; (ii) an attenuated, replication-defective orthopoxvirus (Modified Vaccinia virus Ankara), encoding for the same neoantigens.
B/BE/20/BVW5	Phase 1b Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of Nous-PEV, with pembrolizumab, in Patients with Unresectable Stage III / IV Cutaneous Melanoma and with Stage IV NSCLC	Nouscom Srl	Humans	The study involves two GMOs: (i) A replication-incompetent adenovirus (GAd20 with deletions of the viral E1, E3 and E4 coding regions) isolated from a gorilla and encoding the PEV neoantigens gene; (ii) an attenuated, replication-defective orthopoxvirus (Modified Vaccinia virus Ankara), encoding for the neoantigens gene.
CYAD-211-001	An open-label phase I, multi-center study to determine the recommended dose of the chimeric antigen receptor T-cell treatment CYAD-211 after a non-myeloablative preconditioning chemotherapy in multiple myeloma patients with relapsed or refractory disease.	Celyad	Humans	BCMA-CAR and ShRNA CD3ζ
B/BE/19/BVW4	Importation of doses of V920 for Emergency Use	Merck Sharp & Dohme B.V.	Humans	Recombinant Vesicular Stomatitis Virus (rVSV) in which the gene encoding for the VSV glycoprotein G has been deleted and replaced with the gene encoding the Zaire Ebola virus (ZEBOV) glycoprotein (GP).
Only notified under the "contained use" procedure. Dossier submitted on 02/12/2019.	A randomized Double-blind, Placebo-controlled First-in-Human, Phase 1/2a Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Monovalent HPV16 and HPV18 Ad26-vectored Vaccine Components and an MVA-vectored HPV16/18 Vaccine Component in Oth	Janssen-Cilag International NV	Humans	Recombinant Adenovirus serotype 26 and MVA Bavarian Nordic strain
CYAD-N2T-005	An open-label, Phase I/II study to assess the safety and clinical activity of NKR-2 treatment administration after non-myeloablative preconditioning chemotherapy in relapse/refractory acute myeloid leukemia or myelodysplasic syndrome patient (DEPLETHINK -	Celyad	Humans	NKG2D-chimeric antigen receptor
ADP-0055-001	A phase I, ascending dose, to evaluate safety and efficacy of ADP A2M4CD8 in HLA-A2+ patients with MAGE-A4 psoitives tumors	Adaptimmune LLC	Humans	MAGE-A4 specific T cell receptor (TCR) with a CD8α co-receptor
CYAD-02-001	An open-label, phase I, multi-center study to determine in relapsed/refractory acute myeloid leukemia or myelodysplasic syndrome patients the recommended dose of CYAD-02 after a non-myeloablative preconditioning chemotherapy followed by a potential CYAD-0	Celyad	Humans	NKG2D-chimeric antigen receptor, ShRNA targeting the endogenous RNA of NKG2D ligands MICA and MICB and truncated CD19 reporter protein
68284528MMY2003	A Phase 3 Randomized Study Comparing JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA, versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects with R	Janssen-Cilag International NV	Humans	Autologous T cells expressing BCMA (B-cell maturation antigen)-CAR
68284528MMY2001	A Phase 1b-2, open-label study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) therapy directed against BCMA in subjets with relapsed or refractory multiple myeloma. Protocol 68284528MMY2001	Janssen-Cilag International NV	Humans	B-cell maturation antigen (BCMA)-chimeric antigen receptor
CYAD-N2L-101	An open-label, Phase I study to assess the safety of multiple doses of CYAD-101, administered after standard FOLFOX chemotherapy in patients with unresectable metastatic colorectal cancer (alloSHRINK-study-Standard cHemotherapy Regimen and Immunotherapy w	Celyad	Humans	NKG2D-chimeric antigen receptor, the truncated CD19 tag and the TIM8 molecule which interferes with the interaction between the natural TCR and endogenous CD3ζ
CYAD-N2T-006	An open-label, phase I study to assess the safety of NKR-2 treatment administrated concurrently with 5-azacytidine in tretment-naïve acute myeloid leukemia or myelodysplastic syndrome patients not candidates for intensive therapy (EPITHINK - EPIgenetic dr	Celyad	Humans	NKG2D-chimeric antigen receptor
Only notified under the "contained use" procedure. Dossier submitted on 29/03/2018.	An Open-label Randomized Phase 1b/2 Study of the Efficacy and Safety of JNJ-64041757, a Live Attenuated Listeria monocytogenes Immunotherapy, in Combination with Nivolumab Versus Nivolumab Monotherapy in Subjects With Advanced Adenocarcinoma of the Lung	Janssen-Cilag International NV	Humans	Genetically modified, live attenuated Listeria monocytogenes (Lm ΔactA/ΔinlB)
Only notified under the "contained use" procedure. Dossier submitted on 25/10/2016.	A multinational, open-label, dose escalation Phase I/II study to assess the safety and clinical activity of multiple administrations of NKR-2 in patients with different metastatic tumor types	Celyad	Humans	NKG2D-chimeric antigen receptor
B/BE/07/BVW1	Phase 1b and Phase 2a clinical trials with an hIL-10-expressing Lactococcus lactis	ActoGeniX N.V.	Humans	Gene coding for the human interleukin-10 (hIL-10)
Only notified under the "contained use" procedure. Dossier submitted on 01/02/2005.	A Controlled, Randomised, Parallel Group, Multicentre Study of the Efficacy and Safety of Herpes Simplex Virus-Thymidine Kinase Gene Therapy (CereproTM), with Subsequent Ganciclovir, for the Treatment of Patients with Operable High-Grade Glioma	Ark Therapeutics Ltd	Humans	Thymidine Kinase (HSV-TK1)
B/BE/00/V15	Development of a combined vaccine against equine influenza and tetanus. Experiment outside containment (clinical trial) for the study of the safety and efficacy of an intramuscular administration of recombinant canarypoxvirus expressing equine influenza v	Merial	Horses	haemagglutinin gene from equine influenza virus A2/Kentucky/94 or equine influenza virus A2/Newmarket/2/93
B/BE/99/VW8	Development of a combined live vaccine against feline leukemia. Experiment outside containment (clinical trial) for the study of the safety of a sucutaneous administration of a recombinant canarypoxvirus expressing FELV genes.	Merial	cats	env and gag genes of the type A virus of feline leukemia (FELV)
B/BE/97/VW9	Development of a live vaccine against feline leukemia. Experiment outside containment (clinical trial) for the study of the safety of a subcutaneous administration of a recombinant canarypoxvirus expressing FELV genes.	Merial	cats	env and gag genes of the type A virus of feline leukemia (FELV)