Actively Recruiting
Loncastuximab Tesirine for the Treatment of Relapsed or Refractory B-Cell Malignancies
Led by University of Washington · Updated on 2026-05-11
20
Participants Needed
1
Research Sites
256 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial tests whether loncastuximab tesirine works to shrink tumors in patients with B-cell malignancies that have come back (relapsed) or does not respond to treatment (refractory). Loncastuximab tesirine is a monoclonal antibody, called loncastuximab, linked to a chemotherapy drug, called tesirine. Loncastuximab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD19 receptors, and delivers tesirine to kill them.
CONDITIONS
Official Title
Loncastuximab Tesirine for the Treatment of Relapsed or Refractory B-Cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Diagnosed with CD19+ relapsed or refractory B-cell non-Hodgkin lymphoma excluding Waldenstrom's macroglobulinemia and marginal zone lymphoma
- For certain groups, relapsed DLBCL, FL, or MCL after CAR T-cell therapy or allogeneic transplant (at least 30 days post-treatment)
- Have measurable nodal or extranodal disease with at least one site measuring 1.5 cm, splenomegaly, or marrow involvement
- Performance status of 0-2 on ECOG scale
- Absolute neutrophil count (ANC) ≥ 1.0 x 10^3/uL or ≥ 0.5 x 10^3/uL if marrow involvement
- Platelet count ≥ 75 x 10^3/uL or ≥ 50 x 10^3/uL if due to disease
- Liver enzymes (ALT, AST, GGT) ≤ 3 times upper limit of normal
- Total bilirubin ≤ 1.5 times upper limit of normal (up to 3 times for Gilbert's syndrome)
- Blood creatinine ≤ 2.0 times upper limit of normal or creatinine clearance ≥ 50 mL/min
- Negative pregnancy test within 7 days before starting treatment for women of childbearing potential
- Women of childbearing potential must use effective contraception during and for 10 months after treatment
- Men with partners of childbearing potential must use condoms during and for 7 months after treatment
You will not qualify if you...
- Previous treatment with loncastuximab tesirine
- Known hypersensitivity to loncastuximab tesirine
- Active second primary cancers other than certain specified non-melanoma skin, prostate, cervical, or breast cancers
- Uncontrolled graft-versus-host disease
- Active hepatitis B or C infection
- Pregnant, breastfeeding, or planning to conceive/father children during the study period and up to 9 months after last dose
- Significant fluid accumulation requiring drainage or causing breathing difficulty
- Active central nervous system lymphoma at screening (treated CNS disease allowed)
- Significant heart or medical conditions that increase risk or affect study participation
- Major surgery, radiotherapy, chemotherapy, or other anti-cancer therapy within 14 days before treatment
- Use of other experimental medication within 14 days before treatment
- Planned live vaccinations after starting study drug
- Any other medical condition judged by the investigator to make participation unsafe or inappropriate
- Currently participating in another investigational study or using an investigational device within 4 weeks before treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
S
Stephen D. Smith
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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