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

Phase 1

• Conditions: B-cell Non-Hodgkin LymphomaDiffuse large B-cell lymphomaNon-Hodgkin lymphomaFollicular lymphoma; MedDRA version: 20.0Level: HLGTClassification code 10025320Term: Lymphomas non-Hodgkin's B-cellSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-000845-15-GB
• Lead Sponsor: Genmab A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-15
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Subject must sign an ICF
2. At least 18 years of age
3. 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 CT or MRI
4. ECOG PS score of 0, 1 or 2
5. Acceptable organ function at screening
6. CD20-positive NHL at most recent representative tumor biopsy
7. If of childbearing potential subject must practicing a highly effective method of birth control
8. A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control
9. Arm 1: Documented DLBCL
- DLBCL, 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 DLBCL and eligible for HDT-ASCT
- DLBCL, NOS
- double-hit or triple-hit DLBCL
- FL Grade 3B

Arm 5: Documented DLBCL and ineligible for HDT-ASCT
- DLBCL, NOS
- double-hit or triple-hit DLBCL
- FL Grade 3B
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 105

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. Positive test results for HTLV-1
10. Suspected active or latent tuberculosis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified