In addition, we show that bbT369 T cells drive greater T cell expansion and durable tumor control compared with unedited controls in vivo using a xenograft NSG mouse model. Collectively, the data support the potential for bbT369 to provide deeper and more durable responses in NHL patients including those with more challenging disease characteristics.
The starting dose of bbT369 is 50x106 CAR+ T cells and a BOIN design is being used for dose escalation/de-escalation decisions during the study. Upon establishment of the RP2D, the phase 2 portion will begin enrollment.
Furthermore, while a fraction of mice (3/5) receiving the unedited anti-CD79a/CD20 dual-targeting CAR T cells experienced late relapses (between 60-80 days following initial tumor clearance), all mice (n=5) receiving bbT369 were fully protected from late relapses (up to day 104 of follow-up). Collectively, the data support a first-in-human trial for bbT369 to evaluate initial safety and efficacy in NHL patients.