A Clinical Study of MK-1045 (CN201) in People With Precursor B-cell Acute Lymphoblastic Leukemia (MK-1045-002)

The main inclusion criteria include but are not limited to:

• Adult participants must be age 18 or older

• Pediatric participants must be at least 2 years old and less than 18 years old.

• Diagnosis of precursor B-cell acute lymphoblastic leukemia (B-ALL) and have more than 5% blasts in the bone marrow by morphological assessment

• Participants with Ph-negative B-ALL with any of the following refractory/relapse criteria:

• Failure to achieve complete remission after initial induction therapy;

• Failure to achieve complete remission after salvage treatment;

• Relapse with first remission duration ≤12 months

• Second or later relapse

• Relapse after allogeneic HSCT

• Participants with Ph-positive B-ALL who have received 2 (or more) tyrosine kinase inhibitors (TKIs) and meet the refractory/relapse criteria above or, those with the T315I mutation

The main exclusion criteria include but are not limited to:

• History of Burkitt's leukemia.

• Received anti-CD19 therapy within 3 months prior to entering the study

• Received allogeneic HSCT within 12 weeks prior to entering the study

• Received prior treatment with chimeric antigen receptor T cell (CAR-T) within 3 months prior to entering the study

• History or presence of clinically relevant central nervous system (CNS) pathology

• History of clinically symptomatic metastases to the central nervous system or meninges, or other evidence of uncontrolled metastases to the CNS or meninges

• History of immunodeficiency, including history of any positive test result for human immunodeficiency virus (HIV) antibody.

• History of serious cardiovascular and cerebrovascular disease

• Has active autoimmune diseases that may relapse