Surovatamig as Consolidation Therapy in Participants with Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma with Unmutated Immunoglobulin Heavy Chain Variable (IGHV) - SOUNDTRACK-C1

Inclusion Criteria

• Inclusion Criteria:
• - Documented diagnosis of CLL/SLL with genomic features defined by unmutated IGHV.
• - Treatment received and response at the end of 1L (first-line) finite therapy.
• -Participants with SLL (except those in CR in Phase III part) must have measurable disease (nodal or extranodal) with at least one measurable target lesion.
• -ECOG performance status of 0 to 2.
• - Adequate haematologic, liver, renal and cardiac function.
• - Female participants: must be either women not of childbearing potential or must use a highly effective form of contraception.
• - Male participants who intend to be sexually active with females of childbearing potential must agree to use barrier contraception (eg, condoms).
• Exclusion Criteria:
• -Suspected or confirmed transformation of CLL/SLL to a more aggressive form of lymphoma (ie, Richter’s transformation, prolymphocytic leukaemia, or DLBCL).
• -Evidence of active or history of Central Nervous System (CNS) involvement by CLL/SLL.
• - History of or ongoing confirmed progressive multifocal leukoencephalopathy.
• - Participants who have any concurrent or history of malignancy.
• - Participants with:
• - Active or uncontrolled infection (including Epstein–Barr virus-EBV) requiring systemic therapy.
• - Participants with known history of Heamophagocytic lymphohistiocytosis (HLH).
• - Human Immunodeficiency Virus (HIV) infection, or participants with chronic or active infection with Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV).
• - Major cardiac abnormalities.
• - Prior CLL/SLL-specific therapies.
• - Requires chronic immunosuppressive therapy for active autoimmune/inflammatory condition or prior allogeneic stem cell or solid organ transplant.
• - Major surgical procedure.
• - Known hypersensitivity to surovatamig or any of the excipients of the product.