What side effects are associated with this type of intervention?

Common treatments for Non-Hodgkin's Lymphoma that involve antibodies targeting specific antigens, such as rituximab, ofatumumab, and obinutuzumab, often have side effects including infusion reactions (fever, chills, and rigors), infections due to immunosuppression, cytopenias (low blood cell counts), and gastrointestinal symptoms (nausea, diarrhea). Infusion reactions are particularly notable during the first cycle of treatment and can be severe, especially in patients with high white blood cell counts.

What prior FDA approvals exist?

Several antibody-based therapies have been approved by the FDA for the treatment of Non-Hodgkin's Lymphoma (NHL). Rituximab, an anti-CD20 monoclonal antibody, is widely used and has shown efficacy in various NHL subtypes. Other anti-CD20 antibodies include ofatumumab and obinutuzumab, which have also been approved for NHL treatment. These therapies work by targeting the CD20 antigen on B-cells, leading to their destruction. Additionally, newer agents like polatuzumab vedotin, an antibody-drug conjugate targeting CD79b, have been approved for relapsed or refractory NHL. These treatments highlight the ongoing advancements in antibody-based therapies for blood cancers.

What other types of research exist?

Promising novel alternatives to GEN3014 for Non-Hodgkin's Lymphoma patients include: 1) Polatuzumab vedotin, an antibody-drug conjugate targeting CD79b, which has shown efficacy in combination with bendamustine and rituximab. 2) Tafasitamab, a monoclonal antibody targeting CD19, often used in combination with lenalidomide. 3) Loncastuximab tesirine, an antibody-drug conjugate targeting CD19, which has shown promising results in relapsed or refractory NHL. These therapies have demonstrated significant clinical activity and are considered promising options for NHL treatment in 2024.

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Monoclonal Antibodies

GEN3014 for Blood Cancers

Phase 1 & 2

Waitlist Available

Research Sponsored by Genmab

Eligibility Criteria Checklist

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

Must have

Anti-CD38 mAb-naive RRMM subjects will be enrolled from ex-US countries

Expansion part A (for DLBCL): ECOG PS 0 or 1

Must not have

Has clinically significant cardiac disease

Known medical history or ongoing hepatitis C infection that has not been cured

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing GEN3014, an antibody medicine, in patients with blood cancers that have come back or didn't respond to previous treatments. GEN3014 helps the immune system find and destroy cancer cells. The study aims to find a safe dose and see how well it works. GEN3014 is part of a new wave of antibody-based therapies designed to enhance the immune system's ability to target and destroy cancer cells.

Who is the study for?

This trial is for adults with certain blood cancers like multiple myeloma or acute myeloid leukemia that have come back or didn't respond to treatment. They should be in a stable condition, not pregnant, and willing to use birth control. People can't join if they've had recent cancer treatments, stem cell transplants, active infections like hepatitis B/C or HIV, central nervous system involvement by the cancer, or are taking other experimental drugs.

What is being tested?

The trial tests GEN3014 (an antibody) for safety and effectiveness in relapsed/refractory blood cancers. It has three parts: finding a safe dose level (Dose Escalation), testing this dose further (Expansion Part A), and comparing GEN3014 with daratumumab (Expansion Part B). Participants will receive either GEN3014 or daratumumab but no placebos.

What are the potential side effects?

Possible side effects of GEN3014 aren't fully known since it's new but may include reactions at the infusion site, immune-related issues due to antibody action on the body's cells, fatigue, nausea, and potential impact on blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

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

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I have never received anti-CD38 monoclonal antibodies for my relapsed or refractory multiple myeloma, and I live outside the US.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My multiple myeloma is worsening despite recent treatment.

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I've had 2 or more treatments for my condition, including one with CD20 therapy.

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I have had a recent bone marrow sample taken.

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I can provide a sample of my tumor for testing.

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My AML has not responded to standard treatments.

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My blood or urine tests show signs of myeloma.

Exclusion Criteria

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

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I have a serious heart condition.

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I have an ongoing or past hepatitis C infection that hasn't been cured.

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I had a stem cell transplant from a donor within the last 3 months.

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My cancer has spread to my brain.

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Side effects from my past cancer treatments have mostly gone away, except for hair loss and nerve issues.

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I have had a stem cell transplant from a donor.

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I have taken less than 140 mg of prednisone or 160 mg of dexamethasone recently.

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I have a condition where my transplanted cells attack my body, and I haven't taken any immune-suppressing drugs in the last 4 weeks.

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I have not received CD38-targeted treatments for my multiple myeloma.

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I have had a stem cell transplant using my own cells.

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I had a stem cell transplant using my own cells within the last 3 months.

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I plan to try for a child during or within a year after the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 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: Number of Participants with Dose Limiting Toxicities (DLTs)

Expansion Part A: Objective Response Rate (ORR) of GEN3014

Expansion Part B: Objective Response Rate (ORR) of GEN3014 IV vs Daratumumab SC in Anti-CD38 mAb-naive RRMM Participants

Secondary study objectives

Dose Escalation: Clinical Benefit Rate (CBR) of GEN3014

Dose Escalation: Duration of Response (DOR) of GEN3014

Dose Escalation: Objective Response Rate (ORR) of GEN3014

+13 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

Active Control

Group I: GEN3014Experimental Treatment1 Intervention

Experimental: GEN3014 Participants in Dose Escalation phase with * Relapsed or refractory myeloid myeloma (RRMM) * R/R acute myeloid leukemia (AML) Participants in Expansion Part A with * RRMM (anti-CD38 mAb-naïve) * RRMM (anti-CD38 mAb-refractory) * R/R diffuse large B-cell lymphoma (DLBCL) * R/R AML Participants in Expansion Part B with • RRMM (anti-CD38 mAb-naïve)

Group II: DaratumumabActive Control1 Intervention

Participants in Expansion Part B with - RRMM (anti-CD38 mAb-naïve)

0 / 20Eligibility 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

The most common treatments for Non-Hodgkin's Lymphoma (NHL) include monoclonal antibodies, such as rituximab, which target specific antigens on the surface of lymphoma cells. These antibodies bind to antigens like CD20, leading to the destruction of the cancer cells through mechanisms such as antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), and direct induction of apoptosis. This targeted approach is crucial for NHL patients as it allows for more precise treatment, potentially reducing damage to healthy cells and improving overall outcomes. The development of new antibodies like GEN3014, which are being studied for their safety and efficacy, represents a promising advancement in the treatment of NHL and other blood cancers.