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Notification report


Full notification file


General information

Notification Number
B/ES/21/05

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
09/03/2021

Title of the Project
Clinical study CRSP-ONC-003 titled: “A Phase 1, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Allogeneic CRISPR-Cas9–Engineered T Cells (CTX130) in Adult Subjects with Advanced, Relapsed or Refractory Renal Cell Carcinoma (RCC) with Clear Cell Differentiation”

Proposed period of release:
01/01/2021 to 31/12/2027

Name of the Institute(s) or Company(ies)
CRISPR Therapeutics AG, Baarerstrasse 14
CH 6300 Zug, Switzerland;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Netherlands;

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

If yes, notification number(s):
B/NL/20/013;

GMO characterization

GMO is a:
Other: mammals

Identity of the GMO:
Genus: Homo; Species: H.Sapiens (T cells genetically modified)

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