Actively Recruiting
A Pilot Study of Loncastuximab Tesirine in Specific Populations of Relapsed/Refractory B-Cell Malignancies
Led by University of Washington · Updated on 2026-05-11
20
Participants Needed
1
Research Sites
29 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating loncastuximab tesirine, a medicine made of an antibody linked to a chemotherapy drug, in adults with certain B-cell cancers that have come back or not responded to previous treatments. This phase II trial focuses on patients with relapsed or refractory B-cell non-Hodgkin lymphoma types, including diffuse large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma. The study aims to see if this targeted treatment can shrink tumors by attaching to cancer cells and delivering chemotherapy directly to them. Participants receive loncastuximab tesirine through an intravenous infusion over 30 minutes on the first day of each 21-day treatment cycle. This treatment continues for up to six cycles unless the cancer progresses or side effects become unacceptable. During the study, patients may also have bone marrow biopsies and aspirations as part of their monitoring. After completing treatment, participants are followed for up to five years to assess long-term outcomes. Throughout the study, participants will be regularly evaluated for tumor response and safety. Researchers will monitor overall response rates and track side effects, including any serious adverse events. Tests and assessments include bone marrow examinations and laboratory evaluations. The study will measure how long the response lasts, progression-free survival, and overall survival over a five-year period. Participants remain under observation after treatment to ensure ongoing safety and collect outcome data.
CONDITIONS
Brief 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 patient aged 18 years or older
- Diagnosed with CD19-positive B-cell non-Hodgkin lymphoma (excluding Waldenstrom's macroglobulinemia and marginal zone lymphoma)
- Relapsed or refractory disease with at least one prior therapy and no better treatment options
- Relapsed diffuse large B-cell lymphoma, follicular lymphoma, or mantle cell lymphoma after CAR T-cell therapy or allogeneic transplant (at least 30 days since those treatments)
- Measurable disease with at least one site measuring 1.5 cm or splenomegaly or marrow involvement
- Eastern Cooperative Oncology Group performance status of 0 to 2
- Absolute neutrophil count (ANC) ≥ 1.0 x 10^3/uL (or ≥ 0.5 x 10^3/uL if marrow involved)
- Platelet count ≥ 75 x 10^3/uL (or ≥ 50 x 10^3/uL if due to disease)
- Liver enzymes (ALT, AST, GGT) ≤ 3 times the upper limit of normal
- Total bilirubin ≤ 1.5 times upper limit of normal (up to 3 times if 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 agree to use highly effective contraception until 10 months after last dose
- Men with partners of childbearing potential must agree to use condoms until 7 months after last dose
You will not qualify if you...
- Previous treatment with loncastuximab tesirine
- Known allergy to loncastuximab tesirine
- Active second primary cancer except certain non-melanoma skin cancers, prostate cancer, cervical cancer, or breast carcinoma in situ
- Uncontrolled graft-versus-host disease
- Active hepatitis B or hepatitis C infection
- Pregnant, breastfeeding, or planning to conceive or father children during the trial and 9 months after last dose
- Significant fluid buildup requiring drainage or causing breathing problems
- Active lymphoma involvement in the central nervous system at screening (history of treated CNS disease allowed)
- Serious heart or other medical conditions that increase risk or make participation unsafe
- Recent major surgery, radiotherapy, chemotherapy, or anti-cancer therapy within 14 days before treatment
- Use of other experimental drugs within 14 days before treatment
- Planned live vaccine after starting treatment
- Any other significant medical issues judged unsafe for participation
- Current participation in another investigational study or device within 4 weeks before starting treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 18 weeks (6 cycles of 21 days each)
Participants receive loncastuximab tesirine intravenously over 30 minutes on day 1 of each 21-day cycle. Treatment repeats for 6 cycles in the absence of disease progression or unacceptable toxicity. Participants may also undergo bone marrow biopsy and aspiration throughout this period.
6 visits (in-person), one per treatment cycle
Duration - Up to 5 years
After completing treatment, participants are followed for safety and overall response for up to 5 years.
Visit frequency varies during follow-up
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
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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