A Phase I Study of ALLO-647 with ALLO-715 CAR T-Cell Therapy in People with Recurrent or Persistent Multiple Myeloma

Share
Print

Full Title

A Single-Arm, Open-Label, Phase 1 Study of the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-715 to Evaluate an Anti-BCMA Allogeneic CAR T Cell Therapy in Subjects With Relapsed/Refractory Multiple Myeloma

Purpose

The purpose of this study is to assess the safety of the investigational treatments ALLO-647 plus ALLO-715 immunotherapy in people with recurrent or persistent multiple myeloma, and to determine the safe dose of ALLO-715 following treatment with ALLO-647.

ALLO-647 is an antibody that binds to a marker (CD52) found on white blood cells. It suppresses the immune system so it will not fight ALLO-715. Patients may also receive the standard chemotherapy drugs fludarabine and cyclophosphamide to help suppress the immune system. Then they will receive ALLO-715.

ALLO-715 is a form of CAR T-cell therapy made from white blood cells (T cells) from a healthy donor. The T cells are genetically modified in the laboratory to identify and kill cancer cells, multiplied, and then given to the patients with multiple myeloma. All treatments in this study 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 multiple myeloma that came back or continues to grow despite three or more regimens of therapy.
  • At least 2 weeks must pass between the completion of prior chemotherapy or radiation therapy and 6 weeks since prior autologous stem cell transplantation and entry into 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 and to inquire about eligibility for this study, please contact Dr. Sham Mailankody at 212-639-2131.

Protocol

19-392

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators