Study of Epcoritamab for Patients with Relapsed, Progressive, or Refractory B-Cell Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called B-cell lymphoma, which affects a part of the immune system. The trial is testing a new treatment called Epcoritamab, also known by its code name GEN3013. Epcoritamab is a solution for injection that is designed to target specific proteins on the surface of cancer cells. The purpose of the study is to find the best dose of Epcoritamab and to see how well it works in treating B-cell lymphoma.

Participants in the study will receive Epcoritamab through injections under the skin. The study will be conducted in phases, starting with a dose-escalation phase to determine the safest and most effective dose. After this, the study will expand to include more participants to further evaluate the treatment’s effectiveness. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of Epcoritamab. The study will also explore whether adjusting the dose can reduce the risk of a side effect known as CRS (Cytokine Release Syndrome), which can cause symptoms like fever and fatigue.

In addition to Epcoritamab, the study may involve other medications such as Paracetamol (also known as acetaminophen), Dexamethasone, Betamethasone, Anakinra, Siltuximab, Diphenhydramine, and Tocilizumab. These medications are used to manage symptoms or side effects during the trial. The study aims to gather information over several years to understand the long-term effects and benefits of Epcoritamab for patients with B-cell lymphoma.

1 joining the trial

Upon joining the trial, the patient will be informed about the study’s purpose and procedures. The trial is designed to evaluate the safety and effectiveness of a new treatment for B-cell lymphoma, a type of cancer affecting certain white blood cells.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility. This includes verifying the diagnosis of B-cell lymphoma and ensuring the patient has previously received at least two lines of therapy.

3 treatment phase 1: dose escalation

The patient will receive epcoritamab through subcutaneous injection. The dose will be gradually increased to determine the maximum tolerated dose. The goal is to find the safest and most effective dose for further study.

4 treatment phase 2: expansion

Once the optimal dose is identified, the patient will continue to receive epcoritamab at this dose. The effectiveness of the treatment will be evaluated using criteria that measure tumor response.

5 treatment phase 3: optimization

In this phase, the treatment regimen may be adjusted to reduce the risk of certain side effects. The patient will continue to receive epcoritamab and be monitored for any adverse reactions.

6 monitoring and follow-up

Throughout the trial, the patient will undergo regular monitoring to assess the treatment’s impact on their health. This includes blood tests and imaging studies to track changes in the lymphoma.

7 end of trial

The trial is expected to conclude by February 2028. At the end of the trial, the patient will have a final assessment to evaluate the overall response to the treatment.

Who Can Join the Study?

  • Patient must be 18 years of age or older. In some countries, if the legal age is 21, only patients 21 years or older can participate.
  • Patient must have a confirmed diagnosis of CD20+ mature non-Hodgkin B-cell lymphoma. This is a type of cancer that affects certain white blood cells.
  • Patient’s disease must have returned, worsened, or not responded to previous treatment with an anti-CD20 monoclonal antibody. This is a type of medicine used to treat lymphoma.
  • Patient must have received at least two previous treatments for their condition.
  • Patient must have a disease that can be measured using imaging tests.
  • Patient must have an ECOG performance status of 0, 1, or 2. This is a scale used to assess how well a patient can perform daily activities. For a specific type of lymphoma called MCL, the status must be less than 2.
  • For a specific part of the study, patients must have certain types of lymphoma: R/R DLBCL, FL grades 1-3A, or MCL. These are different subtypes of lymphoma.

Who Cannot Join the Study?

  • Patients who do not have Lymphoma of B-cell origin cannot participate. Lymphoma is a type of cancer that affects the immune system, and B-cells are a specific type of white blood cell.
  • Patients who are not within the specified age range for the study cannot participate. The age range is determined by the study and may include specific age groups.
  • Patients who are not part of the specified clinical trial groups cannot participate. These groups are defined by the study based on certain characteristics or conditions.
  • Patients who are not female or male subjects cannot participate. The study is open to both genders.
  • Patients who are not considered part of a vulnerable population cannot participate. Vulnerable populations may include groups that require special protection in research.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Vivantes Netzwerk fuer Gesundheit GmbH Berlin Germany
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o. Slupsk Poland
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy Bydgoszcz Poland
Centre Henri Becquerel Rouen France
Odense University Hospital Odense Denmark
Ospedale San Raffaele S.r.l. Milan Italy
Region Skane Skanes Universitetssjukhus Lund Sweden
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Karolinska University Hospital Solna Sweden
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Pratia S.A. Skorzewo Poland
Rigshospitalet Copenhagen Denmark
Pirkanmaan hyvinvointialue Tampere Finland
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Ugmcwljfkclqbeijuulrn Erhiy Ato Essen Germany
Ihaqgifu Comvkc Dpxvuejxjinkrnasy L'hospitalet De Llobregat Spain
Savlhig Nd Kpexzht Gqvrc Nbc Hivmmuev Cracow Poland
Uhspghlxno Hhatorrd Ccthlxa Cologne Germany
Iehscnts Rwyifzjax Pbs Lb Slynde Dtw Togrnt Dxua Ageufai Imtb Stkkbj Meldola Italy
Amuiqwgoy Upd Amsterdam The Netherlands
Uloquve Umobrkljzb Hxjyvtey Uppsala Sweden
Huqsafqz Uapxbuicww Cwktuhw Hvwbjrje Helsinki Finland
Esyanlu Unjxgrxcqflx Mxguhzc Csbjggc Rcadshbzt (nwfiunh Mna Rotterdam The Netherlands
Cmhnsp Hfyaqjbqblf Rrolfyjo Umvruppwlxuzg Dq Thrqd Tours France
Adlpjcf Ormnpazcmkn Njtmehdgr Ss Awklles E Bfhciz E C Afwwic Awsmalwqqba Alexandria Italy
Nmktxwgh Icdohsyu Oxtaoszvl Izn Maxlw Skwsylvykqhzcpwdoldbwffxgrik Igmtrgik Bxhinqnu Cracow Poland
Kgijuelo dkq Uybnwamhicpd Muygywhr Aoa Munich Germany
Agmavfe Uhkqr Srdknoaah Llyrzs Dk Bodwusk Bologna Italy
Utqwsmtyiugcou Cfkpgtr Kympakizk Gdansk Poland
Hsmmskcr Utlwoxuvqswee Hitmngjn Tohmm y Picubf Iufijyfs Cgzoof djbqrrpkbuqzrutob (pcba Badalona Spain
Helptqqk Vdue depkgoun Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Not recruiting
28.02.2018
Finland Finland
Not recruiting
28.02.2018
France France
Not recruiting
28.02.2018
Germany Germany
Not recruiting
28.02.2018
Italy Italy
Not recruiting
28.02.2018
Poland Poland
Not recruiting
28.02.2018
Spain Spain
Not recruiting
28.02.2018
Sweden Sweden
Not recruiting
28.02.2018
The Netherlands The Netherlands
Not recruiting
28.02.2018

Trial locations

GEN3013 is a medication being studied in this clinical trial. It is being tested in patients who have B-cell lymphoma that has returned, is getting worse, or has not responded to previous treatments. The trial aims to find the best dose of GEN3013 that patients can tolerate and to see how effective it is in treating the lymphoma. The study also looks at whether changing the way the medication is given can help reduce the risk of certain side effects.

Investigated diseases:

Lymphoma of B-cell origin – This is a type of cancer that begins in the B cells, which are a type of white blood cell responsible for producing antibodies. It typically starts in the lymph nodes but can also affect other organs. The disease progresses as the cancerous B cells multiply uncontrollably, forming tumors in the lymphatic system. Over time, it can spread to other parts of the body, including the spleen, liver, and bone marrow. Symptoms may include swollen lymph nodes, fatigue, fever, and weight loss. The progression and symptoms can vary depending on the specific subtype of B-cell lymphoma.

Trial ID:
2023-504802-12-00
Protocol code:
GCT3013-01
Trial Phase:
Phase I and Phase II (Integrated) – First administration to humans

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