Acute Lymphoblastic Leukemia (ALL) Clinical Trials

• Ph-IIC, Dose Escalation and Dose Expansion: Aged 18 years or older (or same or greater than legal age within the country if it is older than 18 years).

• Ph-IIRa and Ph-IIMa: Aged ≥ 17 years at time of informed consent.

• Ph-IIRb and Ph-IIMb: Age ≥ 12 years and \< 17 years at time of informed consent.

• Ph-IIR, Ph-IIC, Dose escalation, Dose Expansion: Participants with R/R B-precursor ALL.

• Relapsed or Refractory B-precursor ALL at any time after first salvage therapy.

• Relapsed B-precursor ALL at any time after allogenic hematopoietic stem cell transplant (HSCT).

• Ph-IIR, Ph-IIC, Dose escalation, Dose expansion: Greater than or equal to 5% blasts in the Bone Marrow per local assessment.

• Ph-IIM: B-precursor ALL and bone marrow blasts (BMB) ≥ 0.01% and \< 5% per local assessment.

• Ph-IIM: Availability of an appropriate archival BM specimen from initial or relapse diagnosis and the screening BM sample.

• Participants aged ≥ 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2.

• Participants aged 16 to \< 18 years old: Karnofsky Performance Score ≥ 50%.

• Participants aged \< 16 years old: Lansky Performance Score ≥ 50%.

• Any Ph+ participant intolerant or refractory to prior tyrosine kinase inhibitors (TKIs) are eligible.

• Ph-IIM: BM function as follows:

‣ Absolute Neutrophil Count (ANC) ≥ 500/μL

⁃ Platelet count ≥ 50 000/μL (transfusion permitted)

⁃ Hemoglobin level ≥ 9 g/dL (transfusion permitted)

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