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 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
Only notified under the "contained use" procedure. Dossier submitted on 24 October, 1996 .	Prospective, open-label, parallel-group, randomized, multicenter trial comparing the efficacy of surgery, radiation, and injection of murine cells producing herpes simplex thymidine kinase vector followed by intravenous ganciclovir against the efficacy of	Genetic therapy, Inc., Sandoz Pharma, Ltd	Humans	Thymidine Kinase (HSV-TK1), neomycin resistance (NeoR)