Trial of the safety and efficacy of epcoritamab in Japanese subjects with R/R B-NH

Phase 1

Recruiting

• Conditions: B-Cell Non-Hodgkin Lymphoma

• Registration Number: JPRN-jRCT2080225312
• Lead Sponsor: Genmab US Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: recruiting
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

Main Inclusion Criteria:
- Must be at least 20 years of age, inclusive
- Japanese subjects
- CD20 positivity at representative tumor biopsy
a. Part 1:
- Diffuse large B-cell lymphoma (de novo or histologically transformed)
- High-grade B-cell lymphoma
- Primary mediastinal large B-cell lymphoma
- Follicular lymphoma
- Marginal zone lymphoma (nodal, extranodal of mucosa-associated lymphoid tissue, or splenic)
- Small lymphocytic lymphoma
b. Part 2 :
Arm 1:
- Diffuse large B-cell lymphoma (de novo or histologically transformed)
- Follicular lymphoma grade 1-3A
- Relapsed or refractory disease and previously treated with at least 2 lines of systemic antineoplastic therapy including at least 1 anti-CD20 mAb-containing therapy.
- Measurable disease by CT, MRI or PET-CT scan
Arm 2:
- R/R FL grade 1, 2 or 3a, stage II, III, or IV, without evidence of transformation.
- Previously treated with at least 1 prior anti-neoplastic agent, including anti-CD20 antibody
- Must have a need for treatment initiation based on symptoms and/ or disease burden (GELF criteria)
- Eligible to receive R2 per investigator determination
Arm 3:
- One of following confirmed histologies (de novo or histologically transformed from FL or nodal marginal zone lymphoma) :
o DLBCL, NOS
o Double-hit or triple-hit DLBCL
- FL Grade 3B.
- T-cell/histiocyte rich LBCL
- International Prognostic Index (IPI) score ?3
- No prior therapy for DLBCL or FL G3B other than nodal biopsy, corticosteroids, or palliative radiotherapy.
- Eligible to receive R-CHOP per investigator determination
Arm 4:
- One of following confirmed histologies (de novo or histologically transformed from FL or nodal marginal zone lymphoma) including:
o DLBCL, NOS.
o Double-hit or triple-hit DLBCL
o FL Grade 3B.
o T-cell/histiocyte rich LBCL
- Relapsed or refractory to at least one prior therapy including at least one prior anti-CD20 antibody.
- Either failed prior autologous hematopoietic stem cell transplantation (ASCT), or ineligible for autologous HSCT
- Eligible to receive GemOx per investigator determination
Arm 5:
- History of histologically confirmed CD20+ FL Grade 1-3a without evidence of transformation.
- In CR or PR per Lugano criteria following first-line or second-line treatment with SOC regimen, including anti-CD20 antibody, and last dose of SOC within 6 months prior to enrollment

Exclusion Criteria

Main Exclusion Criteria:
- Primary CNS lymphoma or CNS involvement by lymphoma at
screening
- Subjects not eligible for high dose therapy with autologous
hematopoietic stem cell transplantation due to personal choice, social
issues, or similar
-Known clinically significant cardiac disease
- Chronic ongoing infectious diseases requiring treatment (excluding
prophylactic treatment)
Exclusion criteria for Part 2, Arms 2 through 5:
Arm 2:
- FL Grade 3b
- Histologic evidence of transformation to an aggressive lymphoma
- Contraindication to rituximab or lenalidomide
- Unwilling or unable to take aspirin prophylaxis or prophylactic
anticoagulant as clinically indicated
Arm 3:
- Contraindication to any of the individual drugs of the R-CHOP regimen
Arm 4:
- Contraindication to any of the individual drugs of the GemOx regimen
Arm 5:
- FL Grade 3b
- Histologic evidence of transformation to an aggressive lymphoma

Study & Design

• Study Type: Interventional
• Study Design: Not specified