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Study of Loncastuximab Tesirine for Relapsed/Refractory Marginal Zone Lymphoma

This study is testing a drug called loncastuximab tesirine (an immunotherapy) in people with Marginal Zone Lymphoma (MZL), a type of slow-growing non-Hodgkin lymphoma. You may be able to join if you are 18 or older, have MZL that has come back or not responded to previous treatments, and have received at least one prior treatment including an anti-CD20 antibody. Researchers want to see how well loncastuximab tesirine works and what its effects (both good and bad) are. The main goals are to measure how many participants have a complete response (meaning all signs of cancer disappear) at 6 and 12 months after starting treatment. This study is currently recruiting about 50 participants.

Study design
This is an open-label study, meaning both you and your doctors will know which treatment you are receiving. It plans to enroll 50 participants.
What's involved
You will receive loncastuximab tesirine as an intravenous infusion (into a vein) on Day 1 of each 21-day cycle for up to 6 cycles. The dose will be 150 µg/Kg for the first two cycles, then 75 µg/Kg for cycles 3-6.
Compensation
Not stated in the trial record.
Follow-up
Researchers will measure complete response rates at 6 months and 12 months after treatment begins.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05296070

Open-label of Loncastuximab Tesirine (ADCT-402) in Relapsed/Refractory Marginal Zone Lymphoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Miami
~50 participants
Updated 2025-09-30 on ClinicalTrials.gov
What's tested:Loncastuximab tesirine 150 µg/KgLoncastuximab tesirine 75µg/Kg

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete Response (CR) rate of Loncastuximab tesirine in relapsed/refractory at 6 months
Measured over 6 months.
+1 more outcome measured

Conditions

Marginal Zone Lymphoma

Explore related trials

Marginal Zone Lymphoma

Where it's being run

4 sites across 4 states
California1
Florida1
Georgia1
Tennessee1

Study leadership

  • Izidore Lossos, MD · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Philip Arlen, PhD
[email protected]
3052435247
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Involvement of ≥3 nodal sites, each with diameter of ≥3 cm
Any nodal or extranodal tumor mass with a diameter of ≥5 cm
B symptoms (fever ≥ 38 degrees Celsius of unclear etiology, night sweats, weight loss \> 10% within the prior 6 months) or other symptoms attributed to disease or specific organ involvement associated with the relapse.
Risk of local compressive symptoms that may result in organ compromise
Splenomegaly or splenic lesion without splenomegaly
Leukopenia attributed to MZL (leukocytes \< 1000/mm3)
Leukemia (\> 5.000 lymphoma cells/mm3)
Threatened organ function, especially for extranodal MZL
Requirement for transfusion or growth factor support attributed to lymphoma
Involvement of 2 or more extranodal sites, with tumor/lesion in each extranodal site ≥1 cm
Progression or relapsed within 24 months after MZL diagnosis in patients previously treated with ≥1 line of systemic therapy 7. Life expectancy \> 3 months. 8. ECOG (Eastern Cooperative Oncology Group ) performance status 0 to 2 (Refer to Appendix A).69 9. Adequate hematologic, hepatic, and renal function tested within 6 weeks prior to the start of therapy (values must not be achieved with growth factors):

What this trial measures

  • Complete Response (CR) rate of Loncastuximab tesirine in relapsed/refractory at 6 months6 months.

    CR rate is defined as the Complete Response (CR)/n, where n is the number of participants. The proportion of patients with best overall response of complete response (CR), per Cheson criteria if disease is not PET (Positron emission tomography)-avid in initial screening and by revised Lugano criteria if screening PET-CT demonstrated PET-avid disease.CR will be defined by a Deauville score of ≤ 3.

  • Complete Response (CR) rate of Loncastuximab tesirine in relapsed/refractory at 12 months12 months.

    CR rate is defined as the Complete Response (CR)/n, where n is the number of participants. The proportion of patients with best overall response of complete response (CR), per Cheson criteria if disease is not PET-avid in initial screening and by revised Lugano criteria if screening PET-CT demonstrated PET-avid disease.CR will be defined by a Deauville score of ≤ 3.