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Clinical Trial Details — Status: Approved for marketing

Administrative data

NCT number NCT05733650
Other study ID # GCT3013-101
Secondary ID
Status Approved for marketing
Phase
First received
Last updated

Study information

Verified date May 2023
Source Genmab
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Must be 18 years of age or older - R/R CD20+ mature B-cell neoplasm - Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0, 1, or 2 - = 2 prior lines of antineoplastic therapy, including = 1 anti-CD20 monoclonal antibody (mAb) - Fluorodeoxyglucose (FDG) positron emission tomography (PET)-avid and measurable disease by computed tomography/magnetic resonance imaging (CT/MRI) - Patients considering the EAP should have no other available therapeutic option and cannot be eligible for other epcoritamab trials. - Patients considering the EAP must be located in proximity to a US site given that the EAP is currently available only in the United States. - Prior to initiating any program-related assessments or procedures, patients (or their legally acceptable representative) must sign an informed consent form (ICF), which indicates the purpose of the program, the procedures required for the program, and confirms the patient's willingness to participate in the program. Exclusion Criteria: - Any prior therapy with an investigational bispecific antibody targeting CD3 and CD20 - Prior treatment with CAR-T therapy within 100 days prior to first epcoritamab administration - Primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma - Confirmed history of or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy. Low-dose prednisolone for rheumatoid arthritis or similar conditions is allowed. - Active hepatitis B or hepatitis C - Known clinically significant cardiac disease - Pregnancy or breastfeeding - Known hypersensitivity to allopurinol or rasburicase

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Genmab AbbVie
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