Treatment of Relapsed or Refractory Diffuse Large B Cell Lymphoma With Ociperlimab (BGB-A1217) in Combination With Tislelizumab (BGB-A317) or Rituximab

Korábbi kezelés

• Receipt of the following treatment:
  • Systemic chemotherapy, targeted small molecule therapy or radiation therapy within 4 weeks (or 5 half lives, whichever is shorter) before first dose of study drug
  • Recent treatment with another monoclonal antibody within 4 weeks before first dose of study drug
  • Investigational treatment within 4 weeks (or 5 half lives, whichever is shorter) before first dose of study drug
  • Treatment with autologous stem cell transplantation within 6 months before first dose of study drug
  • Treatment with allogeneic hematopoietic stem cell transplantation or organ transplantation
  • Treatment with anti-programmed cell death protein-1 (PD-1), anti PD-L1, anti PD-L2, anti T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT), anti CTLA4 or other antibody or drug specifically targeting T cell costimulation or checkpoint pathways.

Más betegség

• Current or history of central nervous system lymphoma
• Active autoimmune diseases or history of autoimmune diseases that may relapse, with the following exceptions:
  • Controlled Type 1 diabetes
  • Hypothyroidism (provided that it is managed with hormone replacement therapy only)
  • Controlled celiac disease
  • Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis, or alopecia)
  • Any other disease that is not expected to recur in the absence of external triggering factors
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply

Egyéb

• Histologically transformed lymphoma

• Histologically confirmed DLBCL NOS (Not Otherwise Specified), Epstein-Barr virus (EBV) + DLBCL NOS, or high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double/triple-hit lymphoma [DHL/THL]), based on the World Health Organization (WHO) 2016 classification of tumors of hematopoietic and lymphoid tissue
  • Cohort 1: participants must have positive tumor programmed cell death ligand-1 (PD-L1) immunohistochemistry (IHC) testing results as determined by local pathologist
  • Cohort 2: Participants must have negative tumor PD-L1 IHC results as determined by a local pathologist in the dose confirmation stage. The dose expansion stage can enroll participants regardless of PD-L1 expression.
• Previously received ≥ 1 line of adequate systemic anti DLBCL therapy, defined as an anti CD20 antibody based chemoimmunotherapy for ≥ 2 consecutive cycles, unless participants had PD before Cycle 2.
• Relapsed or refractory disease before study entry, defined as either:
  • Recurrent disease after having achieved disease remission (complete response or partial response) during or at the completion of the latest treatment regimen.
  • Stable disease or progressive disease (PD) at the completion of the latest treatment regimen.
• Ineligible for high dose therapy/hematopoietic stem cell transplantation
• Measurable disease as assessed by computed tomography (CT) or magnetic resonance imaging (MRI) and defined as at least 1 lymph node > 1.5 cm in the longest diameter and/or at least 1 extranodal lesion > 1.0 cm in the longest diameter, and measurable lesion (s) in 2 perpendicular diameters