The present investigator-initiated, open, randomized, controlled, Phase II study ISA-HC-NK (EudraCT: 2020-000994-26) compares XNK’s candidate drug combined with Sanofi’s anti-CD38 antibody Isatuximab with Isatuximab alone as consolidation therapy following autologous stem cell transplantation in patients with newly diagnosed multiple myeloma.
The clinical study, which is being conducted at the Huddinge campus of Karolinska University Hospital, includes a total of 60 patients, with 30 patients in each treatment arm.
“Combining NK cells that mediate antibody dependent cellular cytotoxicity (ADCC) with targeted antibodies is an appealing concept. The idea envisioned is a synergistic effect with reduced toxicity, helping to maintain multiple myeloma patients in a disease-free stage. This study is unique since it is the first investigator-initiated study randomizing patients to an NK cell-based therapy,” said Hareth Nahi, Associate Professor at Karolinska Institutet and Principal Investigator for the study.