Study on the Safety, Effectiveness, and Behavior of Mosunetuzumab Alone in Patients with Certain B-Cell Cancers

Sponsor: Genentech, Inc.

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05207670

Provider View

This clinical trial is testing a new treatment called mosunetuzumab, given as an injection under the skin, to see if it is safe and effective for patients with certain types of B-cell cancers, which are a form of non-Hodgkin's lymphoma.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how well mosunetuzumab works, how safe it is, and how it behaves in the body when given to patients with specific B-cell cancers, a type of non-Hodgkin's lymphoma. The study will involve patients receiving mosunetuzumab as a subcutaneous injection, and researchers will monitor the effects on their cancer and any side effects.

Eligibility Criteria

Inclusion Criteria

  • Have at least one tumor that can be measured by scans, with specific size requirements.
  • Be in good general health, with a performance status score of 0, 1, or 2, meaning fully active or with some restrictions but able to carry out light work.
  • Have good blood cell counts and no active infections.
  • Test negative for HIV, unless stable on treatment with a controlled viral load and no recent serious infections.
  • Women of childbearing age must agree to use birth control or abstain from sex, and men must agree to use condoms or abstain from sex.

Specific to Cohorts A1 and A2:

  • Have untreated follicular lymphoma (FL) needing treatment.
  • Have good kidney function.

Specific to Cohort B:

  • Be 80 years or older, or 65-79 years old with certain health limitations making them ineligible for standard chemotherapy.
  • Have untreated diffuse large B-cell lymphoma (DLBCL) needing treatment.
  • Have good organ function.

Specific to Cohort C:

  • Have untreated marginal zone lymphoma (MZL) needing treatment.
  • Have good kidney function.

Specific to Cohort D:

  • Have mantle cell lymphoma (MCL) that has returned or not responded to previous treatment.
  • Have good kidney function.

Specific to Cohort E:

  • Have transformed follicular lymphoma (tFL) or Richter's transformation (RT) that has returned or not responded to previous treatment.
  • Have good kidney function.

Exclusion Criteria

  • Have or had cancer in the brain or spinal cord.
  • Have been treated with mosunetuzumab before.
  • Have severe allergies to certain types of antibodies.
  • Have active infections like hepatitis B, hepatitis C, or HIV, unless controlled.
  • Have had a live vaccine recently.
  • Have had a solid organ or stem cell transplant.
  • Have autoimmune diseases like lupus or rheumatoid arthritis.
  • Have other serious health conditions that could interfere with the study.
  • Have had recent major surgery or radiation therapy.
  • Have unresolved side effects from previous cancer treatments.
  • Have significant heart or lung disease.

Specific to Cohorts D and E:

  • Have had recent treatment with certain types of cancer drugs.

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