Search the database for deliberate release of GM medicinal products

Displaying 1 - 5 of 5

EU record number	Title	Company / Sponsor	Treated organism	Genetic modification
B/BE/25/BVW6	A phase 1, placebo-controlled, randomised, participant- and assessor-blind, single-centre study to assess the safety and immunogenicity of 2 dosages of Nipah measles vector vaccine (MV-NiV) administered subcutaneously either a single dose or as 2 consecut	University of Tokyo	Humans	A live attenuated virus (LAV)-MV-NiV, including the full genome of a live-attenuated measles virus (MV) strain, genetically engineered to express the glycoprotein G of the Nipah virus.
Only notified under the "contained use" procedure. Dossier submitted on 23 October, 2024 .	A Phase 2, randomized, open-label, controlled study to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe refractory idiopathic inflammatory myopathies.	Novartis Pharma Services AG	Humans	CD19 CAR
Only notified under the "contained use" procedure. Dossier submitted on 23 October, 2024 .	Phase II study evaluating rapcabtagene autoleucel in participants with diffuse cutaneous systemic sclerosis (dcSSc)	Novartis Pharma Services AG	Humans	CD19 CAR
Only notified under the "contained use" procedure. Dossier submitted on 14 October, 2015 .	A phase II, single-arm, multi-center trial to determine the efficacy and safety of CTL019 in pediatric patients with relapsed and refractory B-cell acute lymphoblastic leukemia	Novartis Pharma Services AG	Humans	Chimeric antigen receptor against CD19
Only notified under the "contained use" procedure. Dossier submitted on 20 August, 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	Humans	Expression of the Wilms' tumour antigen 1 (WT1)- specific T cell receptor (TCR)