bhng 0A 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 is a multicenter, single arm, open-label, combined 2-part phase 1/2 dose escalation and expansion study in adult subjects with R/R B-ALL, evaluating the safety, tolerability, pharmacokinetic (PK), and efficacy of 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 adults (age ? 18 years) 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 adults. 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 and will be conducted at approximately 40 sites. The study will consist of up to a 3-week screening and pre-phase period, a treatment period, a safety follow-up visit 30 (? 3) days after last dose of study treatment, and a long-term follow-up period (for Ph2 only) lasting approximately 2 years after the first dose of investigational product (IP) is received.
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