Gilead Sciences voluntarily paused two studies of its investigational CAR-T cell therapy, KITE-753, in diffuse large B-cell lymphoma (DLBCL), subsequently aligning with the FDA on a partial clinical hold.
PALISADES-1 and -2, evaluating KITE-753 in 2L and 3L+ R/R diffuse large B-cell lymphoma, have been placed on a partial clinical hold, the company revealed in its third-quarter earnings call. According to Gilead, the hold is in place so that the company can “investigate safety differences we have noted between phase 1 and phase 2.”
On the investor call, Gilead clarified that there were no grade 5 adverse events and that the company is looking at grade 3 and grade 4 ICANS in a “small number of patients.”
KITE-753 is a bicistronic CD19/CD20 CAR T-cell therapy featuring a parallel CAR design to target two tumor antigens, synergistic CD28/4-1BB costimulation to enhance T-cell function, and rapid manufacturing to preserve naive and stem cell memory T cells. Gilead picked up the drug through its $11.9 billion buyout of Kite Pharma in 2017.
PALISADES-1 is a phase 1/2 open-label, multicenter study evaluating the safety and efficacy of KITE-363 or KITE-753, in patients with relapsed/refractory B-cell lymphoma. PALISADES-2 is a phase 3, randomized, open-label multicenter clinical trial comparing KITE-753 against Yescarta for relapsed/refractory large B-cell lymphoma.
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