The Phase I part of the study aims to evaluate the safety, efficacy, and tolerability of subcutaneous (SC) blinatumomab for treatment of Relapsed or Refractory B cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL), to determine the maximum tolerated dose (MTD), and recommended phase 2 dose(s) (RP2D) of SC administered blinatumomab. The Phase II part of the study will evaluate the safety, efficacy, and tolerability of SC blinatumomab for treatment of R/R B-ALL and Minimum Residual Disease Positive (MRD+) B-ALL in participants 12 years old and greater. It will also conduct a clinical pharmacokinetic (PK) evaluation of SC1 and SC2 blinatumomab formulations.
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Dose Escalation Phase: Number of participants who experience dose limiting toxicities (DLTs)
Timeframe: Up to 29 days
Dose Escalation Phase: Number of participants who experience one or more treatment-emergent adverse events (TEAEs)
Timeframe: Up to approximately 28 weeks
Dose Escalation Phase: Number of participants who experience one or more serious TEAEs
Timeframe: Up to approximately 28 weeks
Dose Escalation Phase: Number of participants who experience one or more treatment-related TEAEs
Timeframe: Up to approximately 28 weeks
Dose Escalation Phase: Number of participants who experience one or more adverse events (AEs) of Interest (AEIs)
Timeframe: Up to approximately 28 weeks
Dose Expansion and Phase 2 Ph-IIR cohort: Number of participants who achieve complete remission (CR) / complete remission with partial hematological recovery (CRh)
Timeframe: Up to 10 weeks
Phase 2 Ph-IIC cohort: Maximum concentration (Cmax) of blinatumomab SC1 and SC2
Timeframe: Up to approximately 4 weeks
Phase 2 Ph-IIC cohort: Average concentration (Cavg) of blinatumomab SC1 and SC2
Timeframe: Up to approximately 4 weeks
Phase 2 Ph-IIC cohort: Time to reach maximum concentration (Tmax) of blinatumomab SC1 and SC2
Timeframe: Up to approximately 4 weeks
Phase 2 Ph-IIC cohort: Area under the concentration-time curve (AUC) of blinatumomab SC1 and SC2
Timeframe: Up to approximately 4 weeks
Phase 2 Ph-IIM cohort: Number of participants who achieve CR with MRD-negative response
Timeframe: Up to 10 weeks