NCT05190705
Loncastuximab Tesirine in WM
Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatmentShayna Sarosiek, MDInvestigator-initiated
~21 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:Loncastuximab TesirineDexamethasone
At a glance
Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Response Rate
Measured over 4 weeks up to 6 months
Conditions
NCT05190705
Where you'd take part
This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Beth Israel Deaconess Medical Center
Boston, Massachusettsno site contact published
Dana Farber Cancer Institute
Boston, Massachusettsno site contact published
Fred Hutch
Seattle, Washingtonno site contact published
Mayo Clinic
Rochester, Minnesotano site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Shayna Sarosiek, MD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
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Eligibility criteria
Inclusion
Clinicopathological diagnosis of Waldenström Macroglobulinemia
Symptomatic disease meeting criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenström macroglobulinemia.
At least 2 prior lines of treatment, including an anti-CD20 monoclonal antibody-containing regimen and a BTK inhibitor.
Age 18 years or older
Measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum serum IgM level of \> 2 times the upper limit normal.
ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
Women of childbearing potential: Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or have or will have complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) while participating in the study; and 2) for at least 9 months after discontinuation from the study. FCBP must be referred to a qualified provider of contraceptive methods if needed.
Men must agree to use a latex condom during sexual contact with a female of childbearing potential (FCBP) even if they have had a successful vasectomy 1) while participating in the study; and 2) for at least 6 months after discontinuation from the study.
Participants must have normal organ and marrow function as defined below:
Absolute neutrophil count ≥1000/ uL. Growth factors are not permitted \<14 days prior to C1D1.
Platelets ≥50,000/ uL. Platelet transfusions are not permitted \<14 days prior to C1D1.
Hemoglobin ≥ 7 g/dL. RBC transfusions are not permitted \<14 days prior to C1D1.
Total bilirubin ≤ 1.5 X ULN, or ≤3 x ULN with documented liver metastases and/or Gilbert's Disease
AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal, or ≤5 X ULN with documented liver metastases
Creatinine clearance ≥ 30 ml/min using Cockcroft/Gault formula
Able to adhere to the study visit schedule and other protocol requirements.
Ability to understand and the willingness to sign a written informed consent document.
Exclusion
Prior treatment with CD19 targeted therapy.
Participants who are receiving any other investigational agents.
Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath) unless proven by cytology to be malignant due to WM.
Pregnant or breastfeeding.
Participants with known CNS lymphoma.
Participants with known history of Human Immunodeficiency Virus (HIV), chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring active treatment. Note: Participants with serologic evidence of prior vaccination to HBV (i.e., HBs Ag-, and anti-HBs+ and anti-HBC-) and positive anti-HBc from IVIG may participate.
Significant cardiovascular disease defined as:
Unstable angina within the past 6 months, or
History of myocardial infarction within the past 6 months
Any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or
Uncontrolled or symptomatic arrhythmias
Participants with a history of Stevens-Johnson syndrome (SJS) or Toxic Epidermal Necrolysis (TEN)
Concurrent systemic immunosuppressant therapy.
Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug.
Recent infection requiring systemic treatment that was completed ≤ 14 days before the first dose of the study drug.
Major surgery within 4 weeks of first dose of study drug.
Participants with ongoing alcohol or drug abuse.
History of a non-lymphoma malignancy, except adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, localized prostate cancer, other adequately treated stage 1 or 2 cancer currently in complete remission, or any other cancer that is in a complete remission.
Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, EKG finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the patient; alter the absorption, distribution, metabolism or excretion of the study drug; or impair the assessment of study results.
Participants with ongoing \>grade 1 toxicities from prior therapy (alopecia any grade and/or grade 2 neuropathy are permitted).
Participants with clinically significant history of liver disease, including cirrhosis or hepatitis (viral, autoimmune, etc).
Participants who are unwilling or unable to comply with the protocol.
What this trial measures
- Overall Response Rate4 weeks up to 6 months
Overall Response Rate= Minor response (\>25%-50% reduction in serum IgM from baseline) + Partial Response (\>50-90% reduction in serum IgM from baseline) + Very Good Partial Response (\>90% reduction in serum IgM from baseline) + Complete Response (resolution of all symptoms, normalization of serum IgM with disappearance of IgM paraprotein, resolution of any adenopathy or splenomegaly).