ADP-A2AFP

P1, N=45, Active, not recruiting, Adaptimmune | Trial completion date: Jul 2036 --> Jul 2025

P1, N=45, Active, not recruiting, Adaptimmune | Recruiting --> Active, not recruiting | Trial completion date: Jun 2026 --> Jul 2036

Pts received conditioning lymphodepletion with fludarabine and cyclophosphamide before infusion of ADP-A2AFP SPEAR T-cells. ADP-A2AFP SPEAR T-cell therapy has been well tolerated. Encouraging early evidence of efficacy was observed, including in pts who had progressed after multiple established therapies. A statistically significant difference in time from screening to ADP-A2AFP infusion between pts maintaining BORs ≥4 months vs <4 months was observed.

Prior to ADP-A2AFP infusion, pts receive a lymphodepletion regimen including fludarabine 30 mg/m^2 once per day for 4 days and cyclophosphamide 600 mg/m^2 once per day for 3 days... ADP-A2AFP SPEAR T-cells for patients with HCC has been well tolerated. There have been no clear reports of T-cell-related on-target or off-target toxicity, and no protocol-defined doselimiting toxicities. There is promising early evidence of efficacy, and these data support continued investigation.