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Study on the Safety and Effectiveness of GEN3017 for Patients with Relapsed or Refractory Hodgkin and Non-Hodgkin Lymphoma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the safety and effectiveness of a new treatment called GEN3017 for patients with certain types of blood cancers, specifically Hodgkin lymphoma and non-Hodgkin lymphoma. These are cancers that affect the lymphatic system, which is part of the body's immune system. The trial aims to find the best dose of GEN3017 and to see how well it works in treating these cancers.

Participants in the study will receive GEN3017 through an injection under the skin. The study will be conducted in two parts. The first part will focus on determining the safest and most effective dose of GEN3017. The second part will expand to include more participants to further assess the treatment's effectiveness. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of GEN3017.

The trial will monitor participants for any side effects and measure how the cancer responds to the treatment. The study is expected to continue until 2027, with the goal of providing valuable information about the potential benefits and risks of using GEN3017 for treating Hodgkin lymphoma and non-Hodgkin lymphoma.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, eligibility is confirmed based on specific criteria such as age, medical history, and tumor characteristics.

    Participants must have a confirmed diagnosis of Hodgkin lymphoma or non-Hodgkin lymphoma with CD30 positivity.

  2. Step 2

    Dose escalation phase

    The initial phase involves determining the appropriate dosage of the medication GEN3017.

    Participants receive increasing doses of GEN3017 to identify the maximum tolerated dose and assess safety.

    The medication is administered subcutaneously.

  3. Step 3

    Monitoring and assessment

    Throughout the trial, participants undergo regular monitoring to evaluate the safety and any side effects of the treatment.

    Assessments include physical exams, blood tests, and imaging studies such as CT or MRI scans.

  4. Step 4

    Expansion phase

    Once the appropriate dose is established, the trial moves to the expansion phase.

    This phase focuses on evaluating the anti-tumor activity of GEN3017 in a larger group of participants.

  5. Step 5

    Completion of trial

    The trial is expected to continue until February 2027.

    Participants will have follow-up visits to monitor long-term effects and overall health.

Who can join the trial?

8 criteria

  • Must be at least 18 years old. In the United States and Australia, participants in a specific group can be at least 16 years old.
  • Must have a confirmed diagnosis of relapsed or refractory (R/R) Hodgkin lymphoma (cHL) or T-cell lymphoma (TCL). Relapsed means the disease has returned after treatment, and refractory means the disease did not respond to treatment.
  • Must have at least one measurable tumor that can be seen on a special type of scan called a fluorodeoxyglucose-positron emission tomography (FDG-PET) scan. This scan helps to identify active cancer areas in the body.
  • Must have a CT scan or MRI showing at least one measurable lymph node or area outside the lymph nodes affected by the disease. A CT scan is a detailed X-ray, and an MRI uses magnets and radio waves to create images of the body.
  • Must have a good general health status, measured by a score called the Eastern Cooperative Oncology Group (ECOG) performance status. This score should be 0 or 1 for those 18 years and older. For those aged 16 to 18 in the US and Australia, a Karnofsky score of more than 60% is required. These scores help assess how well a person can perform daily activities.
  • Must have a tumor that tests positive for CD30 before starting the study treatment. CD30 is a protein found on some cancer cells.
  • For a specific group in the study, participants must have relapsed or have a progressive form of Hodgkin lymphoma after receiving at least two or three previous treatments. Progressive means the disease is getting worse.
  • Alternatively, participants can be refractory to the second line of therapy, meaning the disease did not respond to the second treatment attempt.

Who cannot join the trial?

1 criterion

  • Patients with Hodgkin lymphoma or non-Hodgkin lymphoma cannot participate. These are types of cancer that affect the lymphatic system, which is part of the body's immune system.
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Investigated drugs

GEN3017 is an investigational medication being studied for its potential to treat certain types of lymphoma, specifically CD30+ classical Hodgkin lymphoma and CD30+ non-Hodgkin lymphoma. The trial aims to find the most effective and safe dose of GEN3017, as well as to evaluate its safety and how well it is tolerated by patients. Additionally, the study seeks to understand the preliminary effectiveness of GEN3017 in reducing or controlling tumor growth in these types of cancer.

What is already known about the treatment

GEN3017 – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory CD30+ classical Hodgkin lymphoma and CD30+ non-Hodgkin lymphoma. It is in the early stages of clinical research, specifically in Phase 1/2a trials, where its safety, tolerability, and optimal dosing are being evaluated. The main therapeutic indication for GEN3017 is its potential to treat certain types of lymphoma. At the molecular level, GEN3017 works by targeting the CD30 protein on the surface of cancer cells, which may help the immune system recognize and destroy these cells. It is classified pharmacologically as a monoclonal antibody.

Investigated diseases

  • Hodgkin Lymphoma

    This is a type of cancer that originates in the lymphatic system, which is part of the body's immune system. It is characterized by the presence of Reed-Sternberg cells, a specific type of abnormal cell. The disease often begins in the lymph nodes and can spread to other parts of the body, including the spleen, liver, and bone marrow. Symptoms may include painless swelling of lymph nodes, fever, night sweats, and weight loss. As the disease progresses, it can affect the body's ability to fight infections. The progression can vary, with some cases remaining localized while others spread more extensively.

  • Non-Hodgkin Lymphoma

    This is a diverse group of blood cancers that include any kind of lymphoma except Hodgkin's lymphomas. It typically originates in the lymphatic system and can involve B-cells or T-cells. The disease can manifest as either indolent (slow-growing) or aggressive (fast-growing) forms. Symptoms often include swollen lymph nodes, fever, night sweats, and unexplained weight loss. Non-Hodgkin lymphoma can spread to other parts of the lymphatic system and beyond, affecting organs such as the liver and spleen. The progression and symptoms can vary widely depending on the specific type and stage of the disease.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-503348-15-00Protocol codeGCT3017-01Estimated enrolment240 patientsSponsorGenmab A/S

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