Celyad obtains FDA approval to initiate the NKR-2 CAR T cells THINK trial in the USA
Corporate press releases March 08, 2017
IND (Investigational New Drug) approval triggers the initiation of the THINK trial in the U.S.
Rosewell Park (NY) and University of Pittsburgh Medical Center – UPMC (PA) approved and ready to enroll patients.
No toxic event in the other patients enrolled in the study so far.
Mont-Saint-Guibert, Belgium - Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered cell-based therapies, today announced that the U.S. FDA authorized the initiation of the THINK trial in the U.S. THINK evaluates NKR-2 CAR-T cells in seven indications, five solid cancers and two hematological malignancies.
“The FDA approval for the THINK trial is an important milestone allowing us to initiate the THINK clinical trial in the USA. We are now looking forward to enrolling the first patients in both solid and hematological arms of the study in the U.S.”, said Christian Homsy, CEO of Celyad.
“I would like to thank the team as well as our partners for the incredible work achieved so far to make the THINK trial progress at such a good pace. In the coming months, all our efforts will be dedicated to the recruitment and follow-up of new patients for each dose-level cohort, but also to the opening of new clinical sites across EU and the U.S.”, remarked Jean-Pierre Latere, Chief Operating Officer at Celyad.