Epcoritamab for Waldenstrom's Macroglobulinemia

LM
LS
Overseen ByLaura S Samples, M.D.
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Must be taking: BTKi
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called epcoritamab for individuals with Waldenstrom's macroglobulinemia (WM), a blood cancer that thickens the blood and impairs normal body function. The researchers aim to determine if epcoritamab can benefit those who have used Bruton tyrosine kinase inhibitors (BTKi) for over a year but still require better outcomes. Ideal candidates are adults with WM who have been on a BTKi, such as zanubrutinib or ibrutinib, for at least 12 months. Participants will receive epcoritamab injections over several months while continuing their current treatment. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

You will continue taking your current BTKi medication during the trial. However, if you are on certain other medications like CYP3A strong inducers or inhibitors, you may need to stop them before joining the trial. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that epcoritamab is likely to be safe for humans?

Previous studies have shown that epcoritamab has a manageable safety profile for patients with Waldenstrom's macroglobulinemia (WM). Research indicates that common side effects include neutropenia, a low level of certain white blood cells, in about 15.3% of patients, and thrombocytopenia, a low platelet count, in about 11.5% of patients. These side effects are typical with cancer treatments and can usually be managed with medical care.

Overall, early findings suggest that patients generally tolerate epcoritamab well. While some may experience side effects like diarrhea, the drug's safety is considered acceptable for those with relapsed or refractory WM, meaning their disease has returned or not responded to previous treatments. This data indicates that epcoritamab could be a safe option for those eligible to join the clinical trial.12345

Why do researchers think this study treatment might be promising?

Epcoritamab is unique because it offers a novel approach to treating Waldenstrom's Macroglobulinemia. Unlike current treatments, which often include drugs like zanubrutinib or ibrutinib targeting specific proteins on cancer cells, epcoritamab is a bispecific antibody. This means it simultaneously binds to two different targets, enhancing the immune system's ability to recognize and destroy cancer cells. Researchers are excited about epcoritamab because its dual-targeting mechanism could potentially lead to more effective and lasting responses in patients with this condition.

What evidence suggests that epcoritamab might be an effective treatment for Waldenstrom's macroglobulinemia?

In this trial, researchers will administer Epcoritamab as consolidative therapy for adults who have been receiving zanubrutinib or ibrutinib. Studies have shown that Epcoritamab can help treat certain blood cancers. Specifically, one study found that 61% of patients with relapsed B-cell lymphoma responded well to the treatment. Another study demonstrated that 95% of patients responded positively after about 15 months. Epcoritamab aids the immune system in identifying and destroying cancer cells. Although information is limited for Waldenstrom's macroglobulinemia, these results suggest it could be a promising treatment option.678910

Who Is on the Research Team?

LS

Laura S Samples, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Are You a Good Fit for This Trial?

This trial is for adults (18+) with Waldenstrom macroglobulinemia who have been on a BTK inhibitor treatment for at least one year. Participants should be able to undergo blood tests, scans, and possibly bone marrow biopsies.

Inclusion Criteria

Ability to swallow and retain oral medication
I have hepatitis B, am on antiviral therapy, and my viral load is undetectable.
I was treated for hepatitis C and now have undetectable virus levels.
See 11 more

Exclusion Criteria

Enrollment in another therapeutic clinical trial for WM at start of epcoritamab or concurrent enrollment in trials impacting anti-cancer therapy efficacy
I have an autoimmune disease or need ongoing immune-suppressing medication.
I have had stomach surgery that affects how I absorb medications.
See 20 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive epcoritamab injections in 28-day cycles for 12 cycles

12 months
Weekly visits during the first cycle, then monthly

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
5 visits (in-person)

Long-term follow-up

Follow-up visits continue every 6 months for 3 years or more

3 years

What Are the Treatments Tested in This Trial?

Interventions

  • Epcoritamab

Trial Overview

The study is testing epcoritamab, an injectable drug given under the skin in cycles alongside ongoing BTKi therapy. The goal is to see if adding epcoritamab helps control WM better after initial BTKi treatment.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: EpcoritamabExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Heart, Lung, and Blood Institute (NHLBI)

Lead Sponsor

Trials
3,987
Recruited
47,860,000+

Citations

Epcoritamab Offers Durable Results in Relapsed B-Cell ...

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600 | FEATURES, EFFICACY ANALYSIS OF 118 CASES ...

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Efficacy and safety of epcoritamab in relapsed or refractory ...

Epcoritamab, a CD3xCD20 bispecific antibody, resulted in deep, durable responses with a manageable safety profile in patients with relapsed/refractory large ...