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* NEW (25-06-2025) *
schering n.v./s.a.
celgene
Search the database for deliberate release of GM medicinal products
Search the database for deliberate release of GM medicinal products
Displaying 1 - 11 of 11
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EU record number
Title
Company / Sponsor
Treated organism
Genetic modification
Only notified under the "contained use" procedure. Dossier submitted on
01/03/2024
.
A Phase 1, Multicenter, Single-arm, Dose--escalation Study of CC 97540 (BMS-986353), CD19-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, Evaluating Safety and Tolerability in Participants with Relapsing Forms of Multiple Sclerosis (RMS) or Progre
Celgene
Humans
CD19 CAR
Only notified under the "contained use" procedure. Dossier submitted on
22/09/2023
.
A Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Idecabtagene Vicleucel (Ide-Cel) with Lenalidomide (LEN) Maintenance Versus Lenalidomide Maintenance Therapy Alone in Adult Participants with Newly Diagnosed Multiple Myeloma (N
Celgene
Humans
BCMA CAR
Only notified under the "contained use" procedure. Dossier submitted on
18/09/2023
.
A Phase 1, Multicenter, Open-Label Study Of CC-97540 (BMS 986353), CD19-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in Participants with Severe, Refractory Systemic Lupus Erythematosus (SLE)
Celgene
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Dossier withdrawn by the notifier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)
bb2121-MM-001
A phase II, multicenter study to determine the efficacy and safety of bb2121 in subjects with relapsed and refractory multiple myeloma
Celgene
Humans
BCMA02 (human B cell maturation antigen)-CAR
Only notified under the "contained use" procedure. Dossier submitted on
24/04/2018
.
A phase 2, single-arm, multi-cohort, multi-center trial to determine the efficacy and safety of jcar017 in adult subjects with aggressive b-cell non-hodgkin lymphoma
Celgene
Humans
EGFRt en chimeric antigen receptor against CD19
68284528MMY2001
A phase III, multicenter, randomized, open-label study to compare the efficacy and safety of bb2121 versus standard triplet regimens in subjects with relapsed and refractory multiple myeloma (RRMM) (KarMMa-3)
Celgene
Humans
BCMA02 (human B cell maturation antigen) -Chimeric antigen receptor
Only notified under the "contained use" procedure. Dossier submitted on
23/11/2016
.
A phase 2, open-label, multi-cohort, single-arm, multi-center trial to determine the safety, feasibility, and efficacy of JCAR015 in adult subjects with B-cell acute lymphoblastic leukemia
Celgene
Humans
Chimeric antigen receptor against CD19
Only notified under the "contained use" procedure. Dossier submitted on
07/04/2014
.
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
Only notified under the "contained use" procedure. Dossier submitted on
08/05/2012
.
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
Only notified under the "contained use" procedure. Dossier submitted on
11/07/2002
.
A European and Canadian multicenter, randomized, double-blind, placebo controlled study to evaluate the efficacy and safety of Ad5FGF-4 in patients with stable angina
Schering N.V./S.A.
Humans
human FGF-4
Showing 1 to 11 of 11 entries