Search the database for deliberate release of GM medicinal products

Displaying 1 - 4 of 4

EU record number	Title	Company / Sponsor	Treated organism	Genetic modification
B/BE/18/BVW7	Phase III trial investigating a AAV vector containing a variant of human factor IX gene administered to adult subjects with severe or moderately-severe hemophilia B	uniQure biopharma B.V.	Humans	Recombinant adeno associated viral vector containing the wild type modified to express the Padua derivative of human coagulation factor IX cDNA
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
Only notified under the "contained use" procedure. Dossier submitted on 29 March 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)