Study on Loncastuximab Tesirine for Treating Waldenström Macroglobulinemia (WM)

Sponsor: Shayna Sarosiek, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05190705

Provider View

This clinical trial is exploring the safety and effectiveness of a new drug, loncastuximab tesirine, for treating patients with Waldenström Macroglobulinemia (WM) who have already tried at least two other treatments.

Patient Parameters

Program Overview

The purpose of this study is to test a new treatment called loncastuximab tesirine for people with Waldenström Macroglobulinemia (WM), a type of blood cancer. This drug is not yet approved for WM but is approved for other uses. It works by targeting a protein on cancer cells and delivering a toxin to kill them. The study will involve about 36 participants who have previously received treatments like rituximab and ibrutinib. Participants will undergo screening, receive the study treatment, and have follow-up visits to monitor their health and the treatment's effects.

Description

This study is a phase II trial, meaning it focuses on evaluating the safety and effectiveness of loncastuximab tesirine in patients with Waldenström Macroglobulinemia (WM) who have already tried at least two other treatments, including an anti-CD20 antibody and a BTK inhibitor. Loncastuximab tesirine is a type of targeted therapy that uses an antibody to deliver a toxin directly to cancer cells. The study will include screening for eligibility, receiving the study treatment, and follow-up visits to assess the treatment's impact. Approximately 36 people will participate in this study, which is supported by ADC Therapeutics.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with Waldenström Macroglobulinemia (WM).
  • Have symptoms that require treatment according to specific medical guidelines.
  • Have tried at least two previous treatments, including an anti-CD20 antibody and a BTK inhibitor.
  • Be 18 years or older.
  • Have measurable disease, with a certain level of immunoglobulin M (IgM) in the blood.
  • Be in good overall health, with a performance status score of 2 or less.
  • Women of childbearing potential must agree to use two forms of birth control or abstain from sex during the study and for 9 months after.
  • Men must agree to use a condom during sex with women of childbearing potential during the study and for 6 months after.
  • Have normal organ and bone marrow function based on specific blood tests.
  • Be able to attend study visits and follow the study requirements.
  • Understand and agree to sign a consent form.

Exclusion Criteria

  • Have had previous treatment targeting CD19.
  • Are currently receiving other experimental treatments.
  • Have significant fluid buildup in the body unless proven to be caused by WM.
  • Are pregnant or breastfeeding.
  • Have known central nervous system lymphoma.
  • Have a history of HIV, hepatitis B, or hepatitis C requiring treatment.
  • Have significant heart disease or recent heart attack.
  • Have a history of severe skin reactions like Stevens-Johnson syndrome.
  • Are taking systemic immunosuppressants.
  • Have received live vaccines within 4 weeks of starting the study drug.
  • Have had a recent infection or major surgery within 4 weeks of starting the study drug.
  • Have ongoing alcohol or drug abuse.
  • Have a history of other cancers, except for certain treated skin or localized cancers.
  • Have any medical condition that could affect the study's safety or results.
  • Have ongoing side effects from previous treatments, except for certain conditions like hair loss or mild nerve damage.
  • Have significant liver disease.
  • Are unable or unwilling to follow the study protocol.

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