T Cells Expressing HER2-specific Chimeric Antigen Receptors(CAR) for Patients With HER2-Positive CNS Tumors

Summary

This study is for patients that have brain cancer. The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting immune cells present in the blood that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise, but have not been strong enough to cure most patients.

The antibody used in this study is called anti-HER2 (Human Epidermal Growth Factor Receptor 2). This antibody sticks to tumor cells because of a substance on the outside of these cells called HER2. Many types of brain tumors are positive for HER2 . HER2 antibodies have been used to treat people with HER2-positive cancers. For this study, the HER2 antibody has been changed so that instead of floating free in the blood it is now attached to T cells. When an antibody is joined to a T cell in this way it is called a chimeric antigen receptor (CAR). These CAR-T cells seem to be able to kill tumors like the one these patients have, but they don't last very long and so their chances of fighting the cancer are limited. Therefore, developing ways to prolong the life of these T cells should help them fight cancer.

These HER2-CAR T cells are an investigational product not approved by the Food and Drug Administration.

The purpose of this study is to find the largest safe dose of HER2-CAR T cells, to learn what the side effects are, and to see whether this experimental intervention might help patients with brain tumors who volunteer to test this new agent.

Conditions

• Brain Tumor, Recurrent
• Brain Tumor, Refractory

Interventions

BIOLOGICAL

HER2-specific T cells

Dosing Schedule 1: Cycle 1 A: 1x10\^7 cells Cycle 2 A: 1x10\^7 cells Cycle 3 A: 1x10\^7 cells Dosing Schedule 2: Cycle 1 A: 1x10\^7 cells Cycle 2 B: 3x10\^7 cells Cycle 3 B: 3x10\^7 cells Dosing Schedule 3: Cycle 1 A: 1x10\^7 cells Cycle 2 B: 3x10\^7 cells Cycle 3 C: 1x10\^8 cells Subsequent cycles\* \*Additional cycles may be administered at ≤ the final cell dose reached in cycle 3, provided that the subject continues to meet eligibility criteria and does not have confirmed progressive disease.

Sponsors & Collaborators

• Center for Cell and Gene Therapy, Baylor College of Medicine

  collaborator OTHER

• The Methodist Hospital Research Institute

  collaborator OTHER

• Baylor College of Medicine

  lead OTHER

Principal Investigators

• Nabil M Ahmed, MD · Baylor College of Medicine - Texas Children's Hospital

• Shoba Navai, MD · Baylor College of Medicine - Texas Children's Hospital

• Meenakshi Hegde, MD · Baylor College of Medicine - Texas Children's Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-04-01

Primary Completion

2022-04-27

Completion

2037-04-30

Countries

• United States

Study Locations