Search the database for deliberate release of GM medicinal products
EU record number
Title
Company / Sponsor
Treated organism
Genetic modification
B/BE/26/BVW3
A phase I/II/III study with a dose determination part followed by an efficacy and safety evaluation, quadruple blind placebo-controlled part and then by a long-term safety follow up part, in ambulant boys with Duchenne Muscular Dystrophy GENETHON
Humans
Non-replicating recombinant vector derived from adeno-associated virus AAV, lacking all AAV viral genes and carrying the human dystrophin (hMD1) gene
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
