A Phase I Study of BFCR4350A in People with Previously Treated Multiple Myeloma

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Full Title

An Open-Label, Multicenter, Phase I Trial Evaluating the Safety and Pharmacokinetics of Escalating Doses of BFCR4350A in Patients with Relapsed or Refractory Multiple Myeloma

Purpose

The purpose of this study is to find the best dose of the investigational drug BFCR4350A that can be used safely in patients with multiple myeloma that has come back or continued to grow despite treatment. BFCR4350A is a bispecific antibody. It binds to two different proteins at the same time: one found on the surface of cancer cells and one found on the surface of T cells in the immune system.

Researchers think that BFCR4350A may strengthen the immune system’s ability to fight cancer cells by activating a patient’s own cells to destroy myeloma cells. BFCR4350A 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 multiple myeloma that has come back or continued to grow despite prior treatment or cannot be treated with standard therapies.
  • Patients should recover from the serious side effects of previous treatments before they receive BFCR4350A.
  • Patients may not have previously received immunotherapy.
  • 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. Alexander Lesokhin at 212-639-3069.

Protocol

20-322

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators