Phase 2 clinical trial to evaluate the efficacy and safety of varnimcabtagene autoleucel for relapsed/refractory adult acute lymphoblastic leukaemia.
Patients with relapsed/refractory adult acute lymphoblastic leukaemia (R/R ALL) are treated in this phase 2 single-arm trial with a Chimeric antigen receptor (CAR) T cell product, varnimcabtagene autoleucel (var-cel). Var-cel has been developed in academia and approved in Spain for the treatment of patients older than 25 years with R/R ALL, under the Hospital Exemption Clause.
This confirmatory EU-based clinical trial in academic centres from 5 different EU countries is necessary for centralised approval via the European Medicines Agency (EMA).
We are working with Prof. Julio Delgado, Oncoimmunotherapy, FRCB-IDIBAPS/HCB, Barcelona (Spain)