This is an open-label, multicenter, phase I study, which primary objective is to characterize the safety and tolerability of PIT565 and to identify maximal tolerated doses (MTDs) and/or recommended doses (RDs), schedule and route of administration in relapsed and/or refractory B-cell Non-Hodgkin lymphoma (R/R B-NHL) and relapsed and/or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL).
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Incidence and severity of Dose Limiting Toxicities (DLTs)
Timeframe: 28 days or 35 days, depending on the dosing schedule
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: 21 months
Frequency of dose interruptions
Timeframe: 21 months
Frequency of dose reductions
Timeframe: 21 months
Dose intensities
Timeframe: 21 months