[M22-132] Phase 1b/2, Open-Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination With Anti-Neoplastic Agents in Subjects With Non- Hodgkin Lymphoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2011220044

Enrollment

132

Registered

2023-03-14

Start date

2023-08-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B-cell non-Hodgkin lymphoma

Interventions

- Arm 2: Dose Expansion Participants with R/R DLBCL will receive the recommended dose of SC epcoritamab in combination with oral ibrutinib and oral lenalidomide in 28 day cycles. - Arm 3: Dose Expansi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Diagnosis of diffuse large B-cell lymphoma (DLBCL) (de novo or histologically transformed from follicular lymphoma or nodal marginal zone lymphoma) with histologically confirmed CD20+ disease, inclusive of the following according to World Health Organization (WHO) 2016 classification and documented in pathology report: --DLBCL, not otherwise specified (NOS). --High-grade B cell lymphoma with MYC and BCL-2 and/or BCL-6 translocations per WHO 2016 ("double-hit" or "triple-hit") Note: High-grade B-cell lymphomas NOS or other double- /triple-hit lymphomas (with histologies not consistent with DLBCL) are not eligible. --Follicular lymphoma Grade 3B. -Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2. -Must have 1 or more measurable disease sites: --A positron emission tomography (PET) /computed tomography (CT) scan demonstrating PET-positive lesion(s) AND --At least 1 measurable nodal lesion (long axis >= 1.5cm and short axis > 1.0 cm) or >= 1 measurable extra-nodal lesion (long axis >= 1.0 cm) on CT scan or MRI.

Exclusion criteria

Exclusion criteria: -Prior treatment with epcoritamab or any other bispecific antibody targeting CD3 and CD20. -Unresolved toxicities from prior anticancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Events (CTCAE, v 5.0), Grade 2 or below, with the exception of alopecia.

Design outcomes

Primary

Measure	Time frame
Dose Limiting Toxicities (DLTs)	—

Countries

Czechia, Denmark, France, Germany, Hungary, Israel, Japan, Korea, Netherlands, Spain, Taiwan, United Kingdom, United States

Contacts

Public ContactContact for Patients and HCP

AbbVie G.K.

AbbVie_JPN_info_clingov@abbvie.com+81-120-587-874

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026