Study on Loncastuximab Tesirine and Mosunetuzumab for Treating Relapsed or Hard-to-Treat Diffuse Large B-Cell Lymphoma

Sponsor: City of Hope Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05672251

Provider View

This clinical trial is testing a new combination of drugs, loncastuximab tesirine and mosunetuzumab, to see if they can help treat patients with diffuse large B-cell lymphoma that has returned or is not responding to treatment.

Patient Parameters

Program Overview

This study is exploring whether a combination of two drugs, loncastuximab tesirine and mosunetuzumab, can effectively treat patients with diffuse large B-cell lymphoma (DLBCL) that has come back or is not responding to other treatments. Loncastuximab tesirine is designed to target and kill cancer cells, while mosunetuzumab may help stop cancer cells from growing and spreading. The trial aims to determine the safety and effectiveness of this treatment combination.

Description

The main goals of this study are to evaluate the safety and effectiveness of the drug combination loncastuximab tesirine and mosunetuzumab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Researchers will look at how well patients respond to the treatment, including how long the response lasts and whether the cancer stops growing or spreading.

Participants will receive both drugs through an IV and will undergo various tests, including scans and blood tests, to monitor their health and the treatment's effects. The study will also explore genetic and immune factors that might influence how patients respond to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of diffuse large B-cell lymphoma or a related subtype.
  • The cancer must have returned or not responded to at least one previous treatment.
  • Must have measurable disease by CT or PET/CT scan.
  • Cancer cells must have specific markers (CD19 and CD20).
  • Must be in good overall health with a performance status score of 0 to 2.
  • Must have adequate blood cell counts and organ function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during and after the study.
  • Men must agree to use condoms or abstain from intercourse during and after the study.

Exclusion Criteria

  • Previous treatment with loncastuximab tesirine or mosunetuzumab.
  • Previous stem cell transplant from a donor.
  • Recent treatment with certain cancer therapies or radiation.
  • Active infections or significant uncontrolled illnesses.
  • Known active hepatitis B, hepatitis C, or HIV infection.
  • Active central nervous system involvement by lymphoma.
  • History of severe allergic reactions to similar drugs.
  • Pregnant or breastfeeding women.
  • Any condition that might make it unsafe to participate in the study.

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