What side effects are associated with this type of intervention?

Common treatments for Non-Hodgkin's Lymphoma, such as bispecific antibodies like Epcoritamab, often lead to side effects including infusion-related reactions, cytokine release syndrome (CRS), and infections due to immunosuppression. Monoclonal antibodies (e.g., rituximab) can cause severe infusion reactions, especially during the first cycle, and may also lead to neutropenia and increased risk of infections. Chemotherapy regimens, frequently used in combination with these antibodies, can result in hematologic toxicities like anemia, thrombocytopenia, and neutropenia, as well as gastrointestinal symptoms such as nausea, vomiting, and diarrhea.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Hodgkin's Lymphoma, including bispecific antibodies similar to Epcoritamab. One notable example is Blinatumomab, a bispecific T-cell engager (BiTE) that targets CD19 on B cells and CD3 on T cells, approved for certain types of B-cell precursor acute lymphoblastic leukemia (ALL) which shares some treatment principles with NHL. Additionally, Rituximab, an anti-CD20 monoclonal antibody, has been widely used in NHL treatment. These therapies leverage the immune system to target and destroy malignant B cells, similar to the mechanism of action of Epcoritamab.

What other types of research exist?

Promising novel alternatives to Epcoritamab for Non-Hodgkin's Lymphoma patients include: 1) Bispecific T-cell engagers (BiTEs) like Blinatumomab, which targets CD19 on B cells and CD3 on T cells. 2) CAR T-cell therapies such as Axicabtagene Ciloleucel (Yescarta) and Tisagenlecleucel (Kymriah), which are engineered to target CD19 on B cells. 3) Antibody-drug conjugates (ADCs) like Polatuzumab Vedotin, which targets CD79b on B cells. These therapies have shown promising results in clinical trials and offer novel mechanisms of action for treating NHL.

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Monoclonal Antibodies

Epcoritamab for B-Cell Lymphoma

Q: What is the mechanism of action of this treatment?

Non-Hodgkin's Lymphoma (NHL) treatments often target specific proteins on cancer cells to enhance the immune system's ability to fight the disease. Epcoritamab, a bispecific antibody, binds to CD3 on T cells and CD20 on B cells, bringing T cells into close proximity with B cells to promote targeted cell killing. This mechanism is crucial for NHL patients as it leverages the body's immune system to specifically target and destroy lymphoma cells, potentially leading to more effective and less toxic treatments. Other common treatments include monoclonal antibodies like rituximab, which also targets CD20 on B cells, and chemotherapy agents that kill rapidly dividing cells. These therapies are designed to reduce tumor burden and improve patient outcomes by directly attacking cancer cells or enhancing the immune response.

Phase 1

Recruiting

Research Sponsored by Genmab

Eligibility Criteria Checklist

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

Must have

Performance status by Lansky or Karnofsky score >= 50 or Eastern Cooperative Oncology Group (ECOG) score <= 2.

Relapsed or primary refractory disease meeting specific criteria including progressive disease, stable disease, partial response, complete response, inability to tolerate second-line CIT, and other conditions.

Must not have

Currently receiving anti-cancer therapy, including chemotherapy, radiotherapy, small molecules, monoclonal antibodies, cell therapy, or other investigational agents.

Known central nervous system (CNS) involvement by lymphoma at screening as confirmed by imaging scans.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, epcoritamab, for children and young adults with aggressive B-cell cancers that have come back or not responded to other treatments. The drug is given as an injection under the skin periodically. The study will check how safe the drug is and how well it works over several years.

Who is the study for?

This trial is for children and young adults (up to age 25) with aggressive B-cell lymphomas that haven't responded well to previous treatments. They should be able to perform daily activities at a certain level, have no other cancers needing treatment, and not currently be on anti-cancer therapies.

What is being tested?

The study tests Epcoritamab's safety and effects in patients with relapsed/refractory mature B-cell neoplasms. Participants will receive the drug through subcutaneous injections over cycles of 28 days and will be monitored for at least three years.

What are the potential side effects?

Potential side effects include reactions at the injection site, general discomfort, possible immune system responses affecting organs, fatigue, blood-related issues, or infections due to weakened immunity.

Eligibility Criteria

Inclusion Criteria

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

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I can do most activities but may need help.

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My cancer has returned or didn't respond to initial treatment.

Exclusion Criteria

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

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I am currently undergoing treatment for cancer.

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My lymphoma has spread to my brain or spinal cord, confirmed by scans.

Select...

I am receiving treatment for another cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 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

Area Under the Concentration Versus Time Curve (AUC) from Time 0 to Time of Last Measurable Concentration within the Dosing Interval (AUCtau)

Maximum Observed Concentration (Cmax)

Number of Participants with Adverse Events (AE)

Secondary study objectives

Duration of CR (DOCR)

Duration of response (DOR)

Number of Participants who Achieve Overall Survival (OS)

+5 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: EpcoritamabExperimental Treatment1 Intervention

Participants will receive subcutaneous (SC) epcoritamab in 28 day cycles.

0 / 5Eligibility 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

Non-Hodgkin's Lymphoma (NHL) treatments often target specific proteins on cancer cells to enhance the immune system's ability to fight the disease. Epcoritamab, a bispecific antibody, binds to CD3 on T cells and CD20 on B cells, bringing T cells into close proximity with B cells to promote targeted cell killing. This mechanism is crucial for NHL patients as it leverages the body's immune system to specifically target and destroy lymphoma cells, potentially leading to more effective and less toxic treatments. Other common treatments include monoclonal antibodies like rituximab, which also targets CD20 on B cells, and chemotherapy agents that kill rapidly dividing cells. These therapies are designed to reduce tumor burden and improve patient outcomes by directly attacking cancer cells or enhancing the immune response.