Phase 2 Study Assessing the Clinical Activity and Safety of Obecabtagene Autoleucel as a Consolidation in Patients With Newly Diagnosed High-risk B-cell Acute Lymphocytic Leukemia (ALL)

Prior treatment

• Pregnant or lactating; women of child-bearing potential (WOCBP) must have negative pregnancy test. WOCBP defined as not post-menopausal for 12 months or no previous surgical sterilization.

Other illness

• Patients with history of Hepatitis B, Hepatitis C, Human Immunodeficiency Virus (HIV) infections, even if under control. (Patients with Hepatitis B core antibody positive alone will not be an exclusion factor if HBV DNA PCR is negative).
• Active and uncontrolled disease/infection as judged by the treating physician

Other

• Unable or unwilling to sign the consent form

• Patients of age .18 years with high-risk B-cell ALL in first remission and \<5% BM blasts with at least one high-risk feature defined as:
• Ph-negative B-cell ALL:
  • KMT2A rearranged ALL
  • Complex cytogenetics as per NCCN 2022
  • Low-hypodiploidy/tetraploidy
  • Philadelphia-like ALL (based on CRLF2 overexpression or recurrent Ph-like genetic fusions)
  • TP53 mutation (variant allele fraction \>2%)
  • Persistent MRD by flow cytometry and/or NGS
• Ph-positive B-cell ALL:
  • IKZF1plus genotype (IKZF1 deletion coexisting with PAX5 or CDKN2A/2B, or PAR1 region deletions) or other high-risk features such as VPRB1 deletion, etc.
  • High WBC (\>30 x 109/L) at initial presentation
  • Persistent MRD by flow cytometry and/or NGS and/or PCR II. Performance status of 0, 1, or 2 III. Adequate organ function with creatinine less than or equal to 1.6 mg/dl, bilirubin less than or equal to 3.5 mg and ALT and AST less than or equal to 5 times institutional upper limit of normal IV. Patients should be CD19 expression positive (\>1%) before enrollment V. Patients with controlled CNS and/or other extramedullary leukemia will be eligible.