A Phase I Study of Glofitamab Alone or in Combination with Obinutuzumab in People with Recurrent or Persistent Non-Hodgkin Lymphoma

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Full Title

A Multicenter, Open-Label, Phase I/II Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of Escalating Doses of Glofitamab (RO7082859) as a Single Agent and in Combination with Obinutuzumab Administered After a Fixed, Single Dose Pre-Treatment of Obinutuzumab (Gazyva/Gazyvaro) in Patients with Relapsed/Refractory B-Cell Non-Hodgkin’s Lymphoma

Purpose

The purpose of this study is to find the highest dose of the investigational drug glofitamab that can be given safely alone or with obinutuzumab in patients with non-Hodgkin lymphoma that came back or continued to grow despite treatment. Glofitamab is a “bispecific antibody” that binds to two different proteins: one found on the surface of cancer cells and one found on the surface of immune cells. Researchers think that glofitamab may strengthen the immune system’s ability to fight cancer cells by activating a patient’s own cells to destroy the tumor. Both drugs are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have NHL that came back or continued to grow despite treatment.
  • At least 4 weeks must have passed since the completion of previous therapy and receipt of the study treatment.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact the office of Dr. Lorenzo Falchi at 646-608-3705.

Protocol

20-569

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators