AFM11-102
PD, haematological toxicity, non-haematological toxicity, ALL
ADVERSE EVENTS, MAY, POLAND
AFM11-102 was a phase 1, multicentre, open-label dose escalation study of AFM11 in patients with R/R CD19 + adult B-precursor ALL conducted at 12 sites in five countries (Austria, Czech Republic, Israel, Poland and Russia) between October 2016 and May 2019. The primary objectives were to determine the MTD (the highest dose at which < 33% of patients experienced a DLT defined as any grade 3 or higher non-haematological toxicity or grade 4 or higher haematological toxicity or any treatment delay ≥ 7 days because of drug-related adverse events AEs) and to evaluate the safety and tolerability of increasing doses and different infusion times of AFM11 in patients with ALL. Secondary objectives included assessment of the PK and antitumour activity of AFM11 after at least 1 cycle of therapy. In addition, the biological activity and PD markers in blood were assessed.