Search the database for deliberate release of GM medicinal products
EU record number
Title
Company / Sponsor
Treated organism
Genetic modification
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 25 July 2022
.
A Phase I/II study to evaluate the feasibility, safety and preliminary efficacy of point-of-care manufactured anti-CD19 CAR T in subjects with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) (CP0101-CLL) – Eup CellPoint B.V. (a Galapagos company)
Humans
CD19 CAR
Only notified under the "contained use" procedure. Dossier submitted on 7 June 2022
.
A phase I/II open label, multicenter study evaluating the feasibility, safety and efficacy of point-of-care manufactured anti-BCMA CAR T cells (BCMACP03) in subjects with relapsed/refractory Multiple Myeloma (r/r MM) (Papilio-1) CellPoint B.V. (a Galapagos company)
Humans
BCMA CAR
B/BE/18/BVW5
A Phase 1b/2a study to assess the safety and tolerability of GM Lactococcus lactis in subjects with Type 1 Diabetes Mellitus Intrexon T1D Partners, LLC
Humans
Biologically contained strain of Lactococcus lactis, genetically modified to secrete human interleukin-10 and proinsulin
