A Phase 1/2 Open-label Study to Investigate the Safety Efficacy and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Adults with Relapsed or Refractory B cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL)

Brief description of study

This study is designed for patients diagnosed with relapsed or refractory B cell precursor acute lymphoblastic leukemia (R/R B-ALL).

This study is a 2-part phase 1/2 dose escalation (administration of increasing doses of an investigational drug) and expansion study in adult subjects with R/R B-ALL which will be evaluating the safety, tolerability, pharmacokinetic (PK), and efficacy of subcutaneous (SC) blinatumomab as monotherapy. The first part (phase 1 [Ph1]) is a dose-finding study to investigate the PK, safety, and clinical activity of escalating dose levels of SC blinatumomab in pediatric in adults with R/R B-ALL. Once a recommended dose has been selected in the phase 1 (Ph 1) part of the study, the phase 2 (Ph2) part will begin to assess the safety and efficacy of the recommended dose level of SC blinatumomab in pediatric (age 12 years and above) and adults (age 18 years and above) . The study will evaluate SC administration of blinatumomab as a potentially more convenient mode of administration and explore higher doses in the dose escalation (Ph1) part of the study.


Clinical Study Identifier: s22-01072


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