Search the database for deliberate release of GM medicinal products
EU record number
Title
Company / Sponsor
Treated organism
Genetic modification
Only notified under the "contained use" procedure. Dossier submitted on 23 October, 2024
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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
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Phase II study evaluating rapcabtagene autoleucel in participants with diffuse cutaneous systemic sclerosis (dcSSc)
Novartis Pharma Services AG
Humans
CD19 CAR
B/BE/21/BVW7
Phase I open-label, dose escalation trial of BI 1831169 monotherapy and in combination with ezabenlimab in patients with advanced or metastatic solid tumors
SCS Boehringer Ingelheim Comm.V
Humans
BI 1831169 is a recombinant live-attenuated Vesicular Stomatitis Virus (rVSV), modified to replace the VSV-G glycoprotein with the Lymphocytic Choriomeningitis Virus glycoprotein in order to minimize the potential of neurotoxicity for humans and skin disease in animals.
Only notified under the "contained use" procedure. Dossier submitted on 14 October, 2015
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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
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