What is the mechanism of action of this treatment?

Monoclonal antibodies are a cornerstone in the treatment of Non-Hodgkin's Lymphoma (NHL), working by targeting specific antigens on lymphoma cells to induce cell death. For instance, rituximab targets CD20 on B-cell lymphomas, leading to cell lysis through immune-mediated mechanisms. Similarly, GEN3017 targets CD30, a marker on certain lymphoma cells, to trigger immune responses that destroy these cells. This targeted approach is crucial for NHL patients as it offers a more precise treatment, potentially reducing side effects and improving efficacy compared to traditional chemotherapy.

What side effects are associated with this type of intervention?

Common treatments for Non-Hodgkin's Lymphoma, particularly monoclonal antibodies like rituximab, ofatumumab, and obinutuzumab, often cause infusion reactions, which can be severe during the first cycle. Other side effects include infections due to immunosuppression, hematologic toxicities such as neutropenia and thrombocytopenia, and non-hematologic toxicities like fatigue, fever, and gastrointestinal symptoms. Long-term risks may include secondary malignancies. Similar side effects can be expected with anti-CD30 monoclonal antibodies like GEN3017.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Hodgkin's Lymphoma, including monoclonal antibodies targeting specific antigens on lymphoma cells. One notable example is brentuximab vedotin, an anti-CD30 monoclonal antibody-drug conjugate, which has been approved for the treatment of relapsed or refractory CD30-expressing lymphomas, including certain types of NHL. Other FDA-approved monoclonal antibodies for NHL include rituximab, ofatumumab, and obinutuzumab, which target the CD20 antigen on B-cells. These therapies have shown efficacy in various subtypes of NHL and are often used in combination with chemotherapy.

What other types of research exist?

Promising, novel alternatives to GEN3017 for Non-Hodgkin's Lymphoma patients include: 1) Chimeric Antigen Receptor (CAR) T-cell therapies targeting CD19, such as axicabtagene ciloleucel and tisagenlecleucel, which have shown high efficacy in relapsed or refractory NHL. 2) Bispecific T-cell engagers (BiTEs) like blinatumomab, which target CD19 and engage T-cells to attack lymphoma cells. 3) Antibody-drug conjugates (ADCs) such as polatuzumab vedotin, which targets CD79b and delivers cytotoxic agents directly to lymphoma cells. These therapies have demonstrated promising results in clinical trials and offer novel mechanisms of action for treating NHL.

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Monoclonal Antibodies

GEN3017 for Lymphoma

Phase 1 & 2

Recruiting

Research Sponsored by Genmab

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed R/R cHL or R/R TCL.

Participants must have at least 1 measurable lesion by fluorodeoxyglucose-positron emission tomography (FDG-PET) scan demonstrating positive lesion compatible with computed tomography (CT)- or magnetic resonance imaging (MRI)-defined anatomical tumor sites and a CT scan (or MRI) with involvement of ≥1 measurable nodal lesion and/or ≥1 measurable extranodal lesion.

Must not have

Chemotherapy within 2 weeks or major surgery within 4 weeks prior to the first dose of GEN3017.

Primary central nervous system (CNS) tumor or known CNS involvement.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing GEN3017, a new injectable drug, in patients whose specific types of cancer have not responded to other treatments. The drug works by targeting and attacking cancer cells with a unique marker.

Who is the study for?

This trial is for adults with relapsed or refractory CD30-expressing Hodgkin and Non-Hodgkin Lymphomas, who have at least one measurable lesion. Participants should be in good physical condition (ECOG score 0-1) and not have received certain recent treatments like chemotherapy, major surgery, or investigational drugs.

What is being tested?

The trial tests GEN3017 as a solo treatment to see how safe it is and how well it works against lymphoma. It's given through under-the-skin injections. Everyone in the study will receive this active drug; there's no placebo group.

What are the potential side effects?

Possible side effects of GEN3017 are not specified here but generally could include reactions at the injection site, immune system responses, fatigue, allergic reactions, and other impacts on organ function based on its pharmacological class.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is a relapsed or refractory classical Hodgkin lymphoma or T-cell lymphoma.

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I have at least one tumor that can be measured on scans.

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My tumor biopsy shows CD30-positivity.

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I am over 18 and can care for myself with minimal assistance, or I am 16-18 with a good level of activity.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had chemotherapy in the last 2 weeks or major surgery in the last 4 weeks.

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My cancer has spread to or originated in my brain.

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I have had a stem cell transplant using my own cells within the last 60 days or a transplant from a donor.

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I haven't taken high doses of steroids or immunosuppressants in the last 2 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose Escalation Part: Number of Participants with Dose Limiting Toxicities (DLTs)

Expansion Part: Objective Response Rate (ORR)

Secondary study objectives

Dose Escalation and Expansion Part: Duration of Response (DOR)

Dose Escalation and Expansion Part: Number of Participants with Anti-drug Antibodies (ADA) to GEN3017

Dose Escalation and Expansion Part: Objective Response Rate (ORR)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: R/R CD30+ cHL CohortExperimental Treatment1 Intervention

Group II: R/R CD30+ TCL CohortExperimental Treatment1 Intervention

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Monoclonal antibodies are a cornerstone in the treatment of Non-Hodgkin's Lymphoma (NHL), working by targeting specific antigens on lymphoma cells to induce cell death. For instance, rituximab targets CD20 on B-cell lymphomas, leading to cell lysis through immune-mediated mechanisms. Similarly, GEN3017 targets CD30, a marker on certain lymphoma cells, to trigger immune responses that destroy these cells. This targeted approach is crucial for NHL patients as it offers a more precise treatment, potentially reducing side effects and improving efficacy compared to traditional chemotherapy.

Clinical Applications of Immuno-PET in Lymphoma: A Systematic Review.