A Phase II Study of AFM13 in People with T-Cell Lymphoma that Has Not Responded to Treatment

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Full Title

A Phase II Open-label Multicenter Study to Assess the Efficacy and Safety of AFM13 in Patients with Relapsed or Refractory CD30-positive Peripheral T-cell Lymphoma or Transformed Mycosis Fungoides (REDIRECT)

Purpose

The purpose of this study is to assess the safety and effectiveness of the investigational drug AFM13 in people with T-cell lymphoma or a type of T-cell lymphoma called transformed mycosis fungoides that continues to grow or came back despite treatment. AFM13 was designed to attach to the CD30 protein on the surface of T-cell lymphoma cells and activate the immune system to recognize and destroy cancer cells. AFM13 is 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 T-cell lymphoma or transformed mycosis fungoides that continues to grow or came back despite treatment.
  • Patients’ cancer cells must be positive for the CD30 protein.
  • Patients should recover from the serious side effects of previous treatments before entering the study.
  • 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 Dr. Steven Horwitz at 646-608-3725.

Protocol

20-461

Phase

II

Investigator