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). Applies to all arms except arm 7.

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 participant 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:

• 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

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 100 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. 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.