Actively Recruiting
Loncastuximab Tesirine in WM
Led by Shayna Sarosiek, MD · Updated on 2025-05-23
36
Participants Needed
4
Research Sites
336 weeks
Total Duration
On this page
Sponsors
S
Shayna Sarosiek, MD
Lead Sponsor
A
ADC Therapeutics S.A.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Loncastuximab Tesirine in WM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinicopathological diagnosis of Waldenström Macroglobulinemia
- Symptomatic disease meeting treatment criteria from the Second International Workshop on Waldenström Macroglobulinemia
- At least 2 prior treatments including an anti-CD20 monoclonal antibody and a BTK inhibitor
- Age 18 years or older
- Measurable disease with serum IgM level greater than 2 times the upper limit normal
- ECOG performance status of 2 or less (Karnofsky 60% or higher)
- Women of childbearing potential must agree to use two reliable contraception methods or abstain from heterosexual intercourse during the study and for 9 months after
- Men must agree to use latex condoms during sexual contact with women of childbearing potential during the study and for 6 months after
- Normal organ and marrow function as defined by specific blood counts and liver and kidney function
- Able to follow study visits and protocol requirements
- Willing and able to sign informed consent
You will not qualify if you...
- Prior treatment with CD19 targeted therapy
- Currently receiving other investigational agents
- Clinically significant third space fluid accumulation unless proven malignant due to WM
- Pregnant or breastfeeding
- Known central nervous system lymphoma
- History of HIV, chronic hepatitis B or C requiring active treatment
- Significant cardiovascular disease including unstable angina or recent myocardial infarction
- Any Class 3 or 4 cardiac disease or uncontrolled arrhythmias
- History of Stevens-Johnson syndrome or Toxic Epidermal Necrolysis
- Concurrent systemic immunosuppressant therapy
- Vaccination with live attenuated vaccines within 4 weeks of first study drug dose
- Recent infection requiring systemic treatment completed 14 days or less before first study drug dose
- Major surgery within 4 weeks of first study drug dose
- Ongoing alcohol or drug abuse
- History of non-lymphoma malignancy except certain treated cancers in remission
- Significant ongoing illness or abnormality that may affect safety or study assessments
- Ongoing toxicities from prior therapy greater than grade 1 except alopecia and grade 2 neuropathy
- Clinically significant liver disease including cirrhosis or hepatitis
- Unwilling or unable to comply with the study protocol
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
4
Fred Hutch
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
S
Shayna Sarosiek, MD
CONTACT
K
Kirsten Meid
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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