Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)

Korábbi kezelés

• Chemotherapy, radiation therapy, or major surgery within 4 weeks prior to the first dose of epcoritamab
• Any prior treatment with a bispecific antibody targeting CD3 and CD20.
• Treatment with CAR-T therapy within 100 days prior to first dose of epcoritamab
• Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
• Receiving immunostimulatory agent
• Prior allogeneic HSCT

Más betegség

• Clinically significant cardiovascular disease
• Positive tests for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
• Known history of seropositivity of human immunodeficiency virus (HIV)
• Active tuberculosis or history of completed treatment for active tuberculosis within the past 12 months
• Current seizure disorder requiring anti-epileptic therapy
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Egyéb

• CNS lymphoma or known CNS involvement by lymphoma at screening as confirmed by MRI/CT scan of the brain and, if clinically indicated, by lumbar puncture
• Neuropathy > grade 1

• Measurable disease defined as ≥1 measurable nodal lesion (long axis >1.5 cm and short axis >1.0 cm) or ≥1 measurable extra-nodal lesion (long axis >1.0 cm) on computed tomography (CT) or magnetic resonance imaging (MRI). Applies to all arms except arm 7.
• Eastern Cooperative Oncology Group (ECOG) PS score of 0, 1 or 2
• Acceptable organ function at screening
• CD20-positive non-Hodgkin lymphoma (NHL) at most recent representative tumor biopsy
• If of childbearing potential participant must practicing a highly effective method of birth control
• A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control
  • Arm 1:
• Newly diagnosed DLBCL
• DLBCL, not otherwise specified (NOS)
• "Double-hit" or "triple-hit" DLBCL
• FL Grade 3B
  • Arm 2: R/R FL
  • Arm 3: Newly diagnosed, previously untreated FL grade 1-3A
  • Arm 4:
• Documented R/R DLBCL and eligible for HDT-ASCT
• DLBCL, NOS
• "Double-hit" or "triple-hit" DLBCL
• FL Grade 3B
  • Arm 5:
• Documented R/R DLBCL and ineligible for HDT-ASCT
• DLBCL, NOS
• "Double-hit" or "triple-hit" DLBCL
• FL Grade 3B
  • Arm 6: Newly diagnosed, previously untreated FL grade 1-3A
  • Arm 7:
• FL Grade 1-3A
• If PR or CR per Lugano criteria following first-line or second-line treatment with SOC regimen, and last dose of SOC within 6 months prior to enrollment.
  • Arm 8:
• Newly diagnosed DLBCL who are not fit to receive full-dose anthracycline
• T-cell/histiocyte rich DLBCL
• "Double-hit" or "triple-hit" DLBCL
• FL Grade 3B
  • Arm 9:
• R/R FL
• Progressed within 24 months of initiating first-line treatment
  • Arm 10:
• Documented R/R DLBCL and eligible for HDT-ASCT
• DLBCL, NOS
• "Double-hit" or "triple-hit" DLBCL
• FL Grade 3B