Hu8F4

P1, N=72, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Jan 2026 --> Jan 2027 | Trial primary completion date: Jan 2026 --> Jan 2027

P1, N=72, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Jan 2024 --> Jan 2026 | Trial primary completion date: Jan 2024 --> Jan 2026

We incubated fluorescently labeled human Mφ with CFSE-labelled target cells (U937-A2 or THP1), that had been pre-treated with Hu8F4 or isotype control antibody (Herceptin), at E:T=10, with or without anti-CD47 F(ab')2. Importantly, combining Hu8F4 with CD47 blockade significantly increased the Hu8F4 activity and together eliminated AML. The role of other phagocytosis checkpoints, such as SIRPα and LILRB-1 also warrant further investigation.

Hu8F4, a first-in-class TCR mimic antibody, was well tolerated with expansion planned at more frequent dose intervals. On-target peripheral blast reduction temporally related to infusion suggests biological activity. Real-time pharmacokinetic data indicate a possible sink effect that may be overcome by a more frequent dosing strategy that is planned.

P1, N=72, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting