Phase Ib/II Study Assessing the Clinical Activity and Safety of Brexucabtagene Autoleucel as a Consolidation in Patients With Relapsed/Refractory (R/R) and Newly Diagnosed B-cell Acute Lymphocytic Leukemia (ALL) Post Cytoreduction With Mini-HCVD-inotuzumab-blinatumomab/HCVAD-inotuzumab-blinatumomab

Korábbi kezelés

• 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
• Prior exposure to brexu-cel or other anti-CD-19 CAR T cell therapy
• No other investigational therapy within the past 14 days

Más betegség

• Active and uncontrolled disease/infection as judged by the treating physician

Egyéb

• Philadelphia positive B-cell ALL
• Unable or unwilling to sign the consent form

• Participants of age ≥18 years with documented relapsed or refractory B-cell ALL
• In the newly diagnosed cohort: Participants of age ≥18 years with high-risk newly diagnosed B-cell ALL defined as:
  • 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)
• Performance status of 0, 1, or 2
• 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
• Participants should be CD19 expression positive (>50%) before enrollment
• Participants with chronic viral infections like Hepatitis B-virus, Hepatitis C virus or Human Immunodeficiency virus I/II will be eligible if they are on therapy and infections are under control.