Search the database for deliberate release of GM medicinal products

Displaying 1 - 4 of 4

EU record number	Title	Company / Sponsor	Treated organism	Genetic modification
B/BE/26/BVW4	A Phase 1/2/3, Open-Label, Dose Escalation, Dose Expansion, and Randomized, Controlled Study to Evaluate the Safety and Efficacy of ATSN-201 Gene Therapy in Subjects with RS1-Associated X-linked Retinoschisis (LIGHTHOUSE)	ASTENA Therapeutics	Humans	Non-replicating recombinant vector derived from adeno-associated virus AAV44.9 carrying functional copies of the human retinoschisin (hRS1) gene.
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
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