A Phase I/II Study of Humanized 3F8 Bispecific Antibody in Pediatric and Adult Patients with Recurrent or Persistent Neuroblastoma, Osteosarcoma, and Other Solid Tumors

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Full Title

Phase I/II study of Humanized 3F8 Bispecific Antibody (Hu3F8-BsAb) in Patients with Relapsed/Refractory Neuroblastoma, Osteosarcoma, and Other GD2(+) Solid Tumors

Purpose

The purpose of this study is to evaluate a treatment called humanized 3F8 bispecific antibody in patients with recurrent or persistent neuroblastoma, osteosarcoma, and other solid tumors that have a protein called GD2 on their surfaces. Humanized 3F8 bispecific antibody is made by genetically combining two antibodies: HuOKT3, which activates a type of immune cell (the T cell), and Hu3F8, which is used to treat patients with neuroblastoma and osteosarcoma. Researchers believe that this combined bispecific antibody will generate a greater immune response against neuroblastoma, osteosarcoma, and other solid tumors that have GD2.

Humanized 3F8 bispecific antibody 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 recurrent or persistent neuroblastoma, osteosarcoma, or another solid tumor that contains GD2.
  • At least 3 weeks must pass since the completion of chemotherapy or immunotherapy (6 weeks for cell-based and checkpoint inhibitor immunotherapies) and entry into the study.
  • This study is for patients age 1 year and older.

For more information about this study and to inquire about eligibility, please contact Dr. Shakeel Modak at 212-639-7623.

Protocol

18-034

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator