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Notification report


Full notification file


General information

Notification Number
B/ES/20/20

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
01/09/2020

Title of the Project
An exploratory phase 1/2 trial to determine recommended phase 2 dose (RP2D), safety and preliminary efficacy of bb2121 (ide-cel) combinations in subjects with refractory/relapsed multiple myeloma (KarMMa-7)

Proposed period of release:
01/01/2021 to 30/03/2023

Name of the Institute(s) or Company(ies)
Celgene Corporation, ;


3. Is the same GMO release planned elsewhere in the Community?
No

Has the same GMO been notified elsewhere by the same notifier?
Yes

If yes, notification number(s):
B/DE/17/PEI3269; B/DE/19/PEI3525; B/DE/19/PEI3673; B/ES/17/18; B/ES/18/26; B/ES/18/30; B/NL/19/005;

GMO characterization

GMO is a:
Other: mammals

Identity of the GMO:
The GMO, referred to as ide-cel (bb2121), is an autologous Homo Sapiens T lymphocyte population transduced with the anti-BCMA02 CAR lentiviral vector (LVV), which encodes a chimeric antigen receptor (CAR) targeting the human B cell maturation antigen (BCMA).

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
HumanHomoSapiens---

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known