20 Participants Needed

Epcoritamab for Waldenstrom Macroglobulinemia

Recruiting at 2 trial locations
Gv
EL
Overseen ByEmma Logan, MSN
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Gottfried von Keudell, MD PhD
Must be taking: Anti-CD20, BTK inhibitors
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
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is being done to determine if epcoritamab can be used to treat participants with previously treated Waldenstrom Macroglobulinemia (WM).The names of the study drug involved in this study is:-Epcoritamab (a type of antibody)

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

You will need to stop taking any BTK inhibitors (like ibrutinib or zanubrutinib) before starting the trial, allowing a washout period (time without taking the medication) of at least 4 half-lives. Additionally, you must stop taking rituximab at least 4 weeks before starting the trial. The protocol does not specify other medications, so please consult with the trial team for guidance on other medications you are taking.

How is the drug Epcoritamab different from other treatments for Waldenstrom Macroglobulinemia?

Epcoritamab is unique because it is a bispecific antibody that targets both CD3 on T-cells and CD20 on B-cells, potentially offering a novel mechanism of action compared to existing treatments like chemotherapy and BTK inhibitors, which do not utilize this dual-targeting approach.12345

Who Is on the Research Team?

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Gottfried von Keudell, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals with Waldenstrom Macroglobulinemia (WM), a type of B-cell lymphoma, who have already undergone treatment. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be excluded based on factors like other medical conditions or treatments that could interfere with the study.

Inclusion Criteria

Serum IgM level >2x upper limit of normal (ULN)
My organ and bone marrow functions meet the required levels.
I have been treated with an anti-CD20 antibody and a BTK inhibitor before.
See 12 more

Exclusion Criteria

Pregnancy, breastfeeding, unwillingness to adhere to contraception guidelines
Current alcohol or drug abuse, psychiatric illness, unstable social situation
I have symptoms of thick blood or high IgM levels and cannot have plasmapheresis.
See 11 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 in cycles, with varying frequency of administration over 12 cycles

12 cycles (approximately 12 months)
Frequent in-clinic visits for drug administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months
Follow-up visits every 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Epcoritamab
Trial Overview The trial is testing Epcoritamab, an antibody designed to target and kill cancer cells in patients with WM who have previously been treated. The goal is to see if this drug is effective as a new therapy option for these patients.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Safety Lead-In EpcoritamabExperimental Treatment1 Intervention
Group II: Phase II EpcoritamabExperimental Treatment1 Intervention

Epcoritamab is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Epkinly for:
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Approved in European Union as Tepkinly for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Gottfried von Keudell, MD PhD

Lead Sponsor

Trials
2
Recruited
50+

Genmab

Industry Sponsor

Trials
76
Recruited
15,300+

Dr. Jan van de Winkel

Genmab

Chief Executive Officer since 2010

PhD in Immunology, University of Utrecht

Dr. Judith Klimovsky

Genmab

Chief Medical Officer since 2019

MD, University of Copenhagen

Published Research Related to This Trial

Ibrutinib monotherapy is preferred for treating Waldenström macroglobulinemia in patients with MYD88 mutations and without CXCR4 mutations, showing better efficacy compared to traditional chemoimmunotherapy or proteasome inhibitors.
For patients with MYD88 and CXCR4 mutations, or those without either mutation, alternative treatments like chemoimmunotherapy or proteasome inhibitors are recommended, while ongoing research into combinations with ibrutinib and novel BTK inhibitors is promising.
How to Sequence Therapies in Waldenström Macroglobulinemia.Sarosiek, S., Treon, SP., Castillo, JJ.[2022]
Waldenstrom macroglobulinemia (WM) primarily affects older males, with common symptoms including fatigue, weight loss, splenomegaly, and lymphadenopathy, based on a study of 15 patients followed for an average of 82 months.
While WM is currently incurable, treatments such as chemotherapy, bortezomib, and thalidomide have been shown to improve therapeutic outcomes.
[Clinical analysis of 15 patients with Waldenstrom macroglobulinemia].Hu, Y., Chen, SL., Zhong, YP., et al.[2015]
In a study of 160 young patients with Waldenström Macroglobulinemia (median age 49), 70% were asymptomatic at diagnosis, and the majority received effective treatments, leading to a favorable overall survival (OS) rate comparable to the general population.
The study found that high-risk patients had significantly shorter 5-year OS rates (92.9%) compared to low-risk patients (100%), highlighting the importance of risk classification and early diagnosis in improving outcomes for young WM patients.
Younger patients with Waldenström Macroglobulinemia exhibit low risk profile and excellent outcomes in the era of immunotherapy and targeted therapies.Varettoni, M., Ferrari, A., Frustaci, AM., et al.[2021]

Citations

How to Sequence Therapies in Waldenström Macroglobulinemia. [2022]
[Clinical analysis of 15 patients with Waldenstrom macroglobulinemia]. [2015]
Younger patients with Waldenström Macroglobulinemia exhibit low risk profile and excellent outcomes in the era of immunotherapy and targeted therapies. [2021]
Efficacy and safety of front-line treatment regimens for Waldenstrom macroglobulinaemia: a systematic review and meta-analysis. [2023]
SOHO State of the Art Updates and Next Questions: Targeted therapies and emerging novel treatment approaches for Waldenström Macroglobulinemia. [2022]
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