NCT05190705

Loncastuximab Tesirine in WM

A Phase II Study Evaluating Loncastuximab Tesirine in Patients With Previously Treated Waldenström Macroglobulinemia

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Shayna Sarosiek, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to examine the safety and effectiveness of loncastuximab tesirine as a possible treatment for participants with Waldenström Macroglobulinemia (WM). The name of the study drug involved in this study is: * Loncastuximab tesirine

Detailed description

This is a single-arm, open-label, phase II study to evaluate the safety and efficacy of loncastuximab tesirine in patients with Waldenström Macroglobulinemia (WM) who have received at least 2 prior treatments, including an anti-CD20 antibody such as rituximab and a BTK inhibitor such as ibrutinib. The U.S. Food and Drug Administration (FDA) has not approved loncastuximab tesirine for Macroglobulinemia (WM) but it has been approved for other uses. Loncastuximab tesirine is a type of therapy called an antibody drug conjugate. This type of treatment is an antibody to CD19, a protein that is typically found on B-cells and plasma cells in patients with Macroglobulinemia (WM). This is a targeted therapy that uses an antibody (immunoglobulin) to deliver a toxin directly to the cancer. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. It is expected that about 36 people will take part in this research study. ADC Therapeutics is supporting this research study by providing funding and the study drug.

Conditions

• Waldenstrom Macroglobulinemia

Interventions

Type	Name	Description
DRUG	Loncastuximab Tesirine	Administered by intravenous infusion
DRUG	Dexamethasone	Taken orally or administered by intravenous infusion

Timeline

• Start date: 2022-02-17
• Primary completion: 2026-05-01
• Completion: 2028-08-01
• First posted: 2022-01-13
• Last updated: 2025-05-23

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study