Posted by Michael Wonder on 28 Feb 2020
Tessa Therapeutics announces U.S. FDA regenerative medicine advanced therapy designation granted to its CD30 CAR-T cell therapy for the treatment of relapsed or refractory CD30-positive classical Hodgkin lymphoma
27 February 2020 - RMAT designation follows positive proof-of-concept data from two independent Phase I/II clinical studies conducted by Baylor College of Medicine and University of North Carolina Lineberger Comprehensive Cancer Center for the autologous T cell therapy.
Tessa Therapeutics today announced that the Company's investigational CD30-directed autologous chimeric antigen receptor T cell (CD30 CAR-T) therapy has been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. FDA for the treatment of patients with relapsed or refractory CD30-positive classical Hodgkin lymphoma.
Tessa expects to initiate its pivotal Phase II multi-site trial in the fourth quarter of 2020.
