A Pilot Study of 131-I Apamistamab and CAR T-Cell Therapy in People with Recurrent or Persistent Leukemia or Lymphoma

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Full Title

Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma

Purpose

CAR T-cell therapies are a form of immunotherapy where some of a patient’s T cells are removed, modified in the laboratory to recognize a protein on cancer cells, multiplied, and returned to the patient to provoke an immune attack against cancer. Sometimes the new T cells cause side effects related to the immune system’s response to the treatment.

The investigational drug 131-I apamistamab is a protein combined with a radioactive form of iodine, which gives off a small amount of radiation. 131-I apamistamab delivers radiation directly to white blood cells that have a protein called CD45 on their surfaces. It kills them, which prevents them from making other proteins associated with the side effects seen in some people who receive CAR T-cell therapy. 131-I apamistamab may also kill other immune cells that prevent CAR T cells from fighting cancer effectively. 

In this study, researchers want to learn whether 131-I apamistamab, given before CAR T-cell therapy, is a safe treatment that causes few or mild side effects in people with B-cell acute lymphoblastic leukemia (B-ALL) or diffuse large B-cell lymphoma (DLBCL) that has come back or continued to grow despite treatment. 131-I apamistamab and CAR T-cell therapy 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 recurrent or persistent B-ALL or DLBCL that is positive for the CD19 protein (the target of the CAR T-cell therapy used in this study).
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Mark Geyer at 646-608-3745.

Protocol

20-382

Phase

I

Disease Status

Relapsed or Refractory

Investigator