Study on the Safety and Effectiveness of Englumafusp Alfa with Obinutuzumab and Glofitamab for Treating Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma

Sponsor: Hoffmann-La Roche

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04077723

Provider View

This clinical trial is testing a new treatment combination involving englumafusp alfa, obinutuzumab, and glofitamab to see if it is safe and effective for patients with B-Cell Non-Hodgkin's Lymphoma that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

The study aims to evaluate the safety and effectiveness of a new treatment involving englumafusp alfa, given with obinutuzumab and glofitamab, for patients with B-Cell Non-Hodgkin's Lymphoma that has come back or not responded to other treatments. The treatment is given through an IV and involves different stages to find the best dose and see how well it works.

Eligibility Criteria

Inclusion Criteria

  • Have a type of blood cancer that shows certain markers (CD19 and CD20) and has returned or not responded to at least one previous treatment.
  • Have no other treatment options that are expected to help.
  • Have at least one tumor that can be measured by a scan.
  • Be able to provide a new biopsy from a safe area if there is more than one tumor.
  • Be in good overall health with a performance status score of 0 or 1, or up to 2 for some participants.
  • Have a life expectancy of at least 12 weeks.
  • Any side effects from previous cancer treatments must be mild or resolved.
  • Have good liver, blood, and kidney function.
  • Test negative for hepatitis B, hepatitis C, and HIV.
  • Agree to use effective birth control methods to prevent pregnancy during and after the study treatment.
  • Women must not be pregnant or breastfeeding and must use two forms of birth control if they are of childbearing potential.
  • Men must agree to use birth control and not donate sperm during and after the study treatment.

Exclusion Criteria

  • Have circulating lymphoma cells or abnormal blood cells.
  • Have an active infection or a history of severe infections.
  • Be pregnant or breastfeeding, or planning to become pregnant during the study.
  • Have had certain previous treatments or therapies within a specified time before starting the study treatment.
  • Have had a solid organ transplant or certain types of stem cell transplants.
  • Have a history of severe allergic reactions to similar treatments.
  • Have a history of brain or central nervous system lymphoma.
  • Have other serious health conditions that could interfere with the study.
  • Have had major surgery or a significant injury recently.
  • Have another type of cancer within the last two years.
  • Have significant heart disease.
  • Have received a live vaccine recently or plan to during the study.
  • Have used certain immunosuppressive medications recently, except for low-dose steroids.

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