A Study of Subcutaneous Blinatumomab Administration in Acute Lymphoblastic Leukemia (ALL) Patients

Inclusion Criteria:

• Aged 18 years or older (or same or greater than legal age within the country if itis older than 18 years).

• Participants with B-precursor ALL with any of the following:

• Either refractory to primary induction therapy or refractory to at least 1salvage therapy OR

• In untreated first, second, third or greater relapse or refractory relapse

• First Relapse is defined as achievement of first Complete Remission (CR) [CR1] during upfront therapy then relapse during or after continuationtherapy

• Primary Refractory disease is defined as the absence of CR after standardinduction therapy

• Refractory relapse is defined as lack of CR after salvage treatment

• Second relapse or later relapse is defined as relapse after achieving asecond CR (CR2) in first or later salvage

• Refractory to salvage is defined as no attainment of CR after salvage

• Relapsed or Refractory at any time after first salvage therapy.

• Relapse at any time after allogenic hematopoietic stem cell transplant (HSCT).

• Greater than or equal to 5% blasts in the Bone Marrow (Exception: IsolatedNon-central nervous system (CNS) extramedullary disease [EMD]).

• Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to

• Participants with relapse or refractory B Cell ALL Ph+ disease and that areintolerant or refractory to prior tyrosine kinase inhibitors (TKIs) are eligible.

The above is a summary, other inclusion criteria details may apply.

Exclusion Criteria:

• Active ALL in the central nervous system (CNS). Presence of greater than 5 whiteblood cells per cubic millimeter in cerebrospinal fluid (CSF) with lymphoblastspresent and/or clinical signs of CNS leukemia.

• History or presence of clinically relevant CNS pathology such as epilepsy, childhoodor adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia,Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis or severe (≥ grade 3) CNS events including immune effector cell-associated neurotoxicitysyndrome (ICANS) from prior chimeric antigen receptor T-cell (CAR T) or other T cellengager therapies.

• Isolated Extramedullary (EM) Disease

• Symptoms and/or signs that indicate an acute or uncontrolled chronic infection, anyother disease or condition that could be exacerbated by the treatment or wouldcomplicate protocol compliance.

• Testicular leukemia

• History of malignancy (with certain exceptions) other than ALL within 3 years priorto start of protocol-specified therapy.

• Allogeneic HSCT within 12 weeks before the start of protocol-specified therapy.

• Cancer chemotherapy within 2 weeks before the start of protocol-specified therapy (with certain exceptions).

• Immunotherapy within 4 weeks before start of protocol-specified therapy. Priorfailed cluster of differentiation (CD19) directed therapy such as prior blinatumomabor CD19 CAR T cells will be allowed, if treatment ended more than 4 weeks prior tostart of protocol therapy therapy and no prior CNS complications.

• Currently receiving treatment in or less than 30 days or 5 half lives since endingtreatment on another investigational study(ies).

• Abnormal screening laboratory parameters.

• Female participant: Expected to breastfeed during treatment and for 96 hours afterthe last dose of investigational product (SC blinatumomab).

The above is a summary, other exclusion criteria details may apply.