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
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 5 June 2024 .	A Phase 2, Open-Label, Randomized, Multicenter Study of KYV 101, an Autologous Fully Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects with Refractory Primary and Secondary Progressive Multiple Sclerosis (KYSA-7)	Kyverna Therapeutics, Inc.	Humans	CD19 CAR
Only notified under the "contained use" procedure. Dossier submitted on 22 March 2016 .	Phase I study to evaluate the safety and immunogenicity of a bivalent recombinant vaccine against human cytomegalovirus (HCMV).	Hookipa Biotech AG	Humans	Two replication-deficient lymphocytic choriomeningitidis virus (rLCMV) vectors, one expressing a truncated gBprotein of HCMV and one expressing the pp65 protein of the human CMV
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