Low Dose Mosunetuzumab for Treating Slow Growing B-Cell Lymphoma

Sponsor: University of Washington

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06442475

Provider View

This phase II clinical trial is exploring the safety, side effects, and effectiveness of mosunetuzumab, a monoclonal antibody, in treating patients with slow growing B-cell lymphoma. The drug may help stop tumor cells from growing and spreading.

Patient Parameters

Program Overview

This study is testing mosunetuzumab, a type of monoclonal antibody, to see if it is safe and effective for patients with slow growing (indolent) B-cell lymphoma. The treatment aims to interfere with the growth and spread of cancer cells.

Description

In this study, patients will receive mosunetuzumab through an IV over 2-4 hours on specific days (1, 8, 15, and 22). During the study, patients will have blood samples taken and undergo PET/CT scans. Additional CT or MRI scans may be done if needed, and oral or rectal swabs may be collected.

After finishing the treatment, patients will have follow-up visits at week 13, at 6 months, and then for up to 5 years, according to the institution's standards.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Able to understand and sign a consent form.
  • Diagnosed with slow growing B-cell non-Hodgkin lymphoma, with no previous treatment for lymphoma (except certain vaccines).
  • Types of lymphoma include:
    • Follicular lymphoma (grade 1-2 or 3A)
    • Marginal zone lymphoma
  • Disease must be at Ann Arbor stage II-IV.
  • No previous lymphoma treatment.
  • Low tumor burden as defined by specific criteria:
    • Tumor mass less than 7 cm
    • Less than 3 nodal sites involved with a diameter over 3 cm
    • No systemic symptoms or enlarged spleen over 16 cm
    • No risk of vital organ compression
    • No fluid buildup in chest or abdomen
    • No high white blood cell count
    • No significant low blood counts
  • Must have measurable disease, with at least one site measuring 1.5 cm or more on scans.
  • ECOG performance status of 0-2.
  • Adequate kidney function (creatinine clearance ≥ 50 mL/min).
  • Liver function tests within specified limits.
  • Negative pregnancy test for women of childbearing potential.
  • Agree to use effective contraception during treatment and for 3 months after.

Exclusion Criteria

  • Severe allergic reaction to monoclonal antibody therapy.
  • History of another primary cancer that could interfere with the study, unless approved by the principal investigator.
  • Active and uncontrolled infections.
  • HIV infection unless well-controlled.
  • Positive for chronic hepatitis B, unless specific conditions are met.
  • Autoimmune disease requiring treatment.
  • History of certain immune system disorders.
  • Significant heart or lung disease.
  • Ongoing use of systemic corticosteroids, except for low doses for non-tumor reasons.
  • Use of monoclonal antibodies within 4 weeks before starting mosunetuzumab.
  • Previous organ transplant.
  • Pregnant or breastfeeding women, or those planning to become pregnant during or shortly after the study.

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