Citius Pharmaceuticals, Inc. announced that the University of Minnesota Masonic Cancer Center intends to expand their ongoing investigator-initiated Phase 1 trial of LYMPHIR (denileukin diftitox) in combination with FDA-approved CAR-T products for the treatment of B-cell lymphomas. The ongoing study, led by Dr. Veronika Bachanova at the University of Minnesota (UMN), will include an additional study site at City of Hope (COH), a world-renowned cancer treatment and research institution, with Dr. Matthew Mei as the principal site investigator at COH. City of Hope is one of only 53 National Cancer Institute (NCI)-designated comprehensive cancer centers in the U.S. Citius is collaborating with the University of Minnesota (UMN) in this investigator-initiated study.

This Phase 1 dose-finding study to evaluate LYMPHIR prior to CAR-T therapies tisagenlecleucel (KYMRIAH), axicabtagene ciloleucel (YESCARTA), or lisocabtagene maraleucel/BREYANZI), in patients with B-cell lymphomas (BCL) (NCT0485525) was initiated in May 2021 and has been expanded to include City of Hope. Enrollment is underway for patients diagnosed with relapsed or refractory BCL, for which treatment with CAR-Ts is planned, and who are considered at high risk for progression after CAR-T therapy.