Condition/Disease
Part 1: Dose Escalation Section ⚫ Incidence, nature, and severity of adverse events (AEs) (according to NCI CTCAE v.5.0 grading), CRS and immune effector cell-related neurotoxic syndromes (ICANS) are graded according to the ASTCT consensus grading criteria. ⚫ Nature and frequency of dose-limiting toxicities (DLT), AEs, PK, and pharmacodynamic properties. ⚫ Serum ALPS12 concentrations and their PK parameters, including maximum serum concentration (Cmax) and area under the plasma concentration-time curve (AUC). ⚫ Incidence of ALPS12 anti-antibody (ADA) and its impact on ALPS12 exposure. Part 2: Extended Section ⚫ Objective response, defined as a confirmed complete response (CR) or partial response (PR) conforming to RECIST v.1.1, as determined by the trial administrator. ⚫ Incidence, nature, and severity of AEs (according to NCI CTCAE v.5.0 grading), CRS and ICANS are graded according to the ASTCT consensus grading criteria. Consensus grading standard grading
