Large B-cell LymphomaNCT05733650
Expanded Access Program for Epcoritamab
A study testing Epcoritamab in people with Large B-cell Lymphoma and Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, run by Genmab.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Large B-cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Primary Mediastinal Large B-cell Lymphoma (PMBCL)
- What is being tested?
- Epcoritamab
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: Expanded Access Program (EAP) to Provide Epcoritamab (GEN3013) to Eligible Patients With Relapsed or Refractory Large B-cell Lymphoma
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.
Read the 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
- Being tested
- Epcoritamab
- Keywords
- Epcoritamab, GEN3013, Diffuse large B-cell lymphoma, Lymphoma, DuoBody-CD3xCD20, Bispecific antibody, Early access, Double-hit DLBCL, Triple-hit DLBCL, Follicular grade 3b, Transformed DLBCL, High-grade B-cell lymphoma, Primary mediastinal large B-cell lymphoma (PMBCL)
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpcoritamabBiological
Also called GEN3013, DuoBody®-CD3xCD20
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
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large B-cell LymphomaStudies of the same condition, open and under way.
- More trials run by GenmabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733650
- Sponsor's protocol ID
- GCT3013-101
- Status last verified
- May 2023
- First submitted
- 23 Jan 2023
- Last updated
- 25 May 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Program (EAP) to Provide Epcoritamab (GEN3013) to Eligible Patients With Relapsed or Refractory Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT05733650
- Acronym / sponsor ID
- GCT3013-101
- 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
- Keywords
- Epcoritamab, GEN3013, Diffuse large B-cell lymphoma, Lymphoma, DuoBody-CD3xCD20, Bispecific antibody, Early access, Double-hit DLBCL
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- GenmabIndustry (pharma, biotech, devices)
- Collaborators
- AbbVie
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpcoritamabAlso: GEN3013, DuoBody®-CD3xCD20Eligible 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. | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
Related trials for Large B-cell Lymphoma
RecruitingPhase 1
Testing the Combination of Anti-cancer Drugs Mosunetuzumab, Polatuzumab Vedotin, and Lenalidomide for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, High Grade B-Cell Lymphoma
Active, not recruitingPhase 2
Rituximab and Combination Chemotherapy With or Without Lenalidomide in Treating Patients With Newly Diagnosed Stage II-IV Diffuse Large B Cell Lymphoma
Ann Arbor Stage II Diffuse Large B-Cell Lymphoma, Ann Arbor Stage III Diffuse Large B-Cell Lymphoma
RecruitingPhase 1
KSV01 Injection for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma (DLBCL)
Active, not recruitingPhase 1
Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia
B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma, B-Cell Prolymphocytic Leukemia
RecruitingPhase 1
HEME-25 Open-Label Feasibility Study of Elranatamab Utilized as Consolidation in Newly Diagnosed Plasmablastic Lymphoma With or Without HIV
Plasmablastic Lymphoma, HIV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Epcoritamab in people with Large B-cell Lymphoma and Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, run by Genmab.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.