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

Key Inclusion Criteria

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)
2. Eastern Cooperative Oncology Group (ECOG) PS score of 0, 1 or 2
3. Acceptable organ function at screening
4. CD20-positive non-Hodgkin lymphoma (NHL) at most recent representative tumor biopsy
5. If of childbearing potential subject must practicing a highly effective method of birth control
6. A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control

Arm 1:

1. Newly Diagnosed Documented diffuse large B-cell lymphoma (DLBCL)
2. DLBCL, NOS
3. "double-hit" or "triple-hit" DLBCL
4. FL Grade 3B

Arm 2: R/R FL

Arm 3: Newly diagnosed, previously untreated FL grade 1-3A

Arm 4:

1. Documented DLBCL and eligible for HDT-ASCT
2. DLBCL, NOS
3. "double-hit" or "triple-hit" DLBCL
4. FL Grade 3B

Arm 5:

1. Relapsed or refractory documented DLBCL and ineligible for HDT-ASCT
2. DLBCL, NOS
3. "double-hit" or "triple-hit" DLBCL
4. FL Grade 3B

Arm 6: Newly diagnosed, previously untreated FL grade 1-3A

Arm 7:

1. FL Grade 1-3A
2. 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:

1. DLBCL, NOS
2. T-cell/histiocyte rich DLBCL
3. "double-hit" or "triple-hit" DLBCL
4. FL Grade 3B

Arm 9:

1. R/R FL
2. Progressed within 24 months of initiating first-line treatment

Arm 10:

1. Documented DLBCL and eligible for HDT-ASCT
2. DLBCL, NOS
3. "double-hit" or "triple-hit" DLBCL
4. FL Grade 3B

Key Exclusion Criteria

1. Chemotherapy, radiation therapy, or major surgery within 4 weeks prior to the first dose of epcoritamab
2. Any prior treatment with a bispecific antibody targeting CD3 and CD20.
3. Treatment with CAR-T therapy within 30 days prior to first dose of epcoritamab
4. Clinically significant cardiovascular disease
5. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
6. 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
7. Active positive tests for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
8. Known history of seropositivity of human immunodeficiency virus (HIV)
9. Active tuberculosis or history of completed treatment for active tuberculosis within the past 12 months
10. Neuropathy > grade 1
11. Receiving immunostimulatory agent
12. Prior allogeneic HSCT
13. Current seizure disorder requiring anti-epileptic therapy

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.