A Phase 1b/2 Study to Investigate the Safety, Efficacy and Pharmacokinetics of Administration of Subcutaneous (SC) Blinatumomab in Pediatric Participants With Relapsed/Refractory (R/R) and Minimal Residual Disease Positive (MRD+) B-Cell Precursor Acute Lymphoblastic Leukemia (B-ALL)
The main objective of this study is to evaluate the safety and efficacy of SC blinatumomab in children below 12 years of age.
• Age ≥28 days to \<12 years at the time of informed consent/assent.
• Lansky Performance Status (LPS) of ≥ 50%.
• For Phase 1b and Phase 2 cohort in participants with R/R B-ALL:
‣ Participants with B-ALL relapsed after or refractory to any line of treatment including allogeneic hematopoietic stem cell transplant (HSCT).
⁃ Greater than or equal to 5% blasts in the bone marrow (BM) is considered as relapse in the BM.
• For Phase 2 cohort in participants with MRD+ B-ALL:
‣ Participants with MRD+ B-ALL must have between ≥ 0.1% and \< 5% blasts in the BM.
• Prior CD19-directed therapy will be allowed (with demonstrated continued CD19+ expression) if treatment ended \>4 weeks prior to start of protocol therapy and no prior central nervous system (CNS) complications.
• Any Philadelphia chromosome-positive (Ph+) participant intolerant or refractory to prior tyrosine kinase inhibitors (TKIs) are eligible.