RecruitingPhase 2NCT05296070

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

A Phase 2, Open-label, Study Evaluating Safety and Efficacy of the Loncastuximab in Relapsed/Refractory Marginal Zone Lymphoma

Sponsor

University of Miami

Enrollment

50 participants

Start Date

Jun 21, 2022

Study Type

INTERVENTIONAL

Conditions

Marginal Zone Lymphoma

Summary

The purpose of this research study is to see if loncastuximab tesirine has any benefits at dose levels researchers found acceptable in earlier studies in patients with related forms of immune cell cancers. The researchers want to find out the effects (good and bad) that loncastuximab tesirine has on the participant and the participant's condition.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a targeted antibody-drug called loncastuximab tesirine (ADCT-402) in people with marginal zone lymphoma (a type of slow-growing blood cancer) that has come back or stopped responding to prior treatments. **You may be eligible if...** - You are 18 or older - You have been diagnosed with marginal zone lymphoma (including nodal, extranodal, or splenic types) confirmed by biopsy - You have received at least one prior treatment, including at least one anti-CD20 antibody treatment (like rituximab), and your cancer has progressed or not responded - Your disease can be measured on imaging scans - You are in reasonably good general health **You may NOT be eligible if...** - You have not received any prior systemic treatment - Your cancer cannot be measured on imaging - You have significant organ problems (liver, kidney, heart) - You are pregnant or breastfeeding - You have active serious infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLoncastuximab tesirine 150 µg/Kg

Participants will be treated with loncastuximab tesirine at a dose of 150 µg/Kg given as an intravenous infusion (given as per treatment guidelines for 30 minutes or longer) on Day 1 (+/- 3 days) of each 21 day cycle for Cycle 1 - 2.

DRUGLoncastuximab tesirine 75µg/Kg

Participants will be treated with loncastuximab tesirine at a dose of 75 µg/Kg given as an intravenous infusion (given as per treatment guidelines for 30 minutes or longer) on Day 1 (+/- 3 days) of each 21 day cycle for Cycle 3 - 6.