A Phase I Study of RO7443904 in Combination with Glofitamab for People with Non-Hodgkin Lymphoma

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Full Title

An Open-Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RO7443904 in Combination with Glofitamab in Participants 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 RO7443904 when given in combination with glofitamab immunotherapy in people with non-Hodgkin lymphoma (NHL) that came back or continues to grow despite treatment. RO7443904 boosts the ability of glofitamab to strengthen the immune system’s ability to fight cancer cells.

People in this study will receive RO7443904 plus glofitamab after treatment with obinutuzumab, a standard therapy for NHL. Researchers think that giving obinutuzumab before glofitamab may decrease the side effects of glofitamab. Participants will receive RO7443904 either intravenously (by vein) or as a subcutaneous injection (under the skin). Glofitamab and obinutuzumab are given intravenously. 

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have persistent or recurrent NHL that is positive for the CD19 and CD20 proteins. Examples include follicular lymphoma, marginal zone lymphoma, diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, and Richter’s transformation.
  • The serious side effects of prior treatments must go away before the study treatment is given.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

Contact

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

Protocol

22-224

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators