Search the database for deliberate release of GM medicinal products

Displaying 1 - 7 of 7

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
B/BE/21/BVW9	Dossier withdrawn by the notifier	ActoGenix	Humans	V181 is a live attenuated dengue quadrivalent vaccine rDENVΔ30 where the four viral components of V181 (one for each serotype) present a deletion of 30 nucleotides in the 3’ non‐coding region (Δ30)
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 7 April 2014 .	A single-center, open-label Phase 1 study to assess safety and medical endoscopic sampling methodology and to characterize the pharmacokinetics of oral doses of AG014 in Healthy Subjects	ActoGenix	Humans	gene expressing certolizumab
B/BE/12/BVW1	A multi-center, randomized, double-blind, placebo-controlled Phase I/II trial to compare the safety, tolerability and immunogenicity of the therapeutic THV01 vaccination of HIV-1 clade B infected patients under highly antiretroviral therapy	TheraVectys	Humans	genes encoding the epitopes of the HIV-1 Gag, Pol and Nef proteins
Only notified under the "contained use" procedure. Dossier submitted on 8 May 2012 .	A single-center, open-label Phase 1 study to assess the effect of food/beverage and to characterisze the pharmacokinetics of single and multiple oral doses of AG013 in Healthy Subjects	ActoGenix	Humans	Human Trefoil Factor 1