Trials / Approved For Marketing
Approved For MarketingNCT05733650
Expanded Access Program for Epcoritamab
Expanded Access Program (EAP) to Provide Epcoritamab (GEN3013) to Eligible Patients With Relapsed or Refractory Large B-cell Lymphoma
- Status
- Approved For Marketing
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Genmab · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
Summary
The purpose of this program is to provide investigational epcoritamab, an antibody also known as GEN3013 (DuoBody-CD3xCD20), in an expanded access setting for eligible patients with relapsed and/or refractory (R/R) large B-cell lymphoma (LBCL) who have a high unmet medical need with no other treatment options. It is a requirement that patients do not qualify for an ongoing epcoritamab clinical program or are unable to participate due to logistical reasons. Access to investigational epcoritamab can be requested by contacting preapprovalaccessprograms@genmab.com.
Detailed description
This is a multicenter program conducted within the United States. The program will consist of screening, treatment (Cycle 1 Day 1 until epcoritamab discontinuation), safety follow-up, post-treatment and/or survival follow-up.
Conditions
- Large B-cell Lymphoma
- Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
- Primary Mediastinal Large B-cell Lymphoma (PMBCL)
- High Grade B-cell Lymphoma (HGBCL)
- Grade 3B Follicular Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Epcoritamab | Eligible patients will receive epcoritamab (28-day cycle) that will be administered as subcutaneous (SC) injections until disease progression, or one or more of the treatment discontinuation criteria are met. |
Timeline
- First posted
- 2023-02-17
- Last updated
- 2023-05-25
Source: ClinicalTrials.gov record NCT05733650. Inclusion in this directory is not an endorsement.