TZ101 / Targazyme - LARVOL DELTA

Cord Blood Regulatory T Cells for Prevention of Graft Versus Host Disease (ASH 2017) - P1/2; "...The subsequent 3 patients underwent peripheral blood (PB) matched unrelated donor (MUD) transplant with Fludarabine/ Melphalan myeloablative conditioining and received fucosylated CB Tregs at a dose of 1 x 10e6/kg. All patients received additional pharmacologic GVHD prophylaxis with sirolimus and mycophenolate mofetil... All patients receiving fucosylated CB Tregs followed by PB MUD transplants exhibited non-infectious high fevers up to 40οC accompanied by an erythematous rash starting on post-transplant day +5 that lasted for 5-7 days and resolved after steroid administration (IV methylprednisolone 1mg/kg) for 24-96 hours... Our group is the first to show safety of infusing 3rd party, ex-vivo expanded CB Tregs in a PB MUD transplant setting. At a dose level of 1.0 x 10e6 /kg, 3rd party CB Tregs were administered without acute infusional toxicity and no negative impact on engraftment. The cause for the high fevers observed in the fucosylated CB Treg recipients is unclear

Biosimilar • Graft versus Host Disease • Hematological Malignancies

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