A Study to Evaluate Adverse Events of Subcutaneous (SC) Epcoritamab Administered in the Outpatient Setting in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma

Conditions

• Classic Follicular Lymphoma
• Diffuse Large B-Cell Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Epcoritamab — DRUG
  Subcutaneous Injection (SC)

Study Details

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). Classic Follicular Lymphoma is a slow-growing type of non-Hodgkin lymphoma. The purpose of this study is to assess the safety of epcoritamab in adult participants in relapsed or refractory (R/R) diffuse large b-cell lymphoma (DLBCL) who have received at least 1 prior line of systemic antilymphoma therapy including at least 1 anti-CD20 monoclonal antibody-containing therapy or R/R classic follicular lymphoma (cFL). Adverse events will be assessed. Epcoritamab is an investigational drug being developed for the treatment of R/R DLBCL and R/R cFL. Study doctors will assess participants in a monotherapy treatment arm of epcoritamab. Participants will receive escalating doses of epcoritamab, until full dose is achieved. Approximately 184 adult participants with R/R DLBCL and R/R cFL will be enrolled in the study in approximately 80 sites in the United States of America. Participants will receive escalating doses of subcutaneous epcoritamab, until full dose is achieved, in 28-day cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Key Dates

Start date

Aug 17, 2022

Status verified

Jan 2025

Primary completion

Mar 31, 2027

Completion

Mar 31, 2027

Study Design

Enrollment

184 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Main Cohort: Epcoritamab Diffuse Large B-Cell Lymphoma (DLBCL)
  Participants with relapsed or refractory (R/R) DLBCL will receive subcutaneous (SC) epcoritamab in 28 day cycles.
• Experimental: Main Cohort: Epcoritamab Classic Follicular Lymphoma (cFL)
  Participants with R/R cFL will receive SC epcoritamab in 28 day cycles.
• Experimental: Diversity Enriched Cohort: Epcoritamab DLBCL
  Participants with R/R DLBCL will receive SC epcoritamab in 28 day cycles.
• Experimental: Diversity Enriched Cohort: Epcoritamab cFL
  Participants with R/R cFL will receive SC epcoritamab in 28 day cycles.

Primary Outcome Measure

Percentage of Participants Experiencing Grade 3 or Higher Cytokine Release Syndrome (CRS) Events [ Time Frame: Up to 3 Months ]

Locations (70)

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