Her2 Chimeric Antigen Receptor Expressing T Cells in Advanced Sarcoma
Status:
Active, not recruiting
Trial end date:
2032-07-01
Target enrollment:
Participant gender:
Summary
Patients have a type of cancer called sarcoma. Because there is no standard treatment for the
patients cancer at this time or because the currently used treatments do not work fully in
all cases, patients are being asked to volunteer to take part in a gene transfer research
study using special immune cells. This research study combines two different ways of fighting
disease: antibodies and T cells. Antibodies are proteins that protect the body from diseases
caused by germs or toxic substances. They work by binding those germs or substances, which
stops them from growing or exerting their toxic effects. T cells, also called T lymphocytes,
are special infection-fighting blood cells that can kill other cells, including tumor cells
or cells that are infected with germs. Both antibodies and T cells have been used to treat
patients with cancers: they both have shown promise, but have not been strong enough to cure
most patients. We have found from previous research that we can put a new gene into T cells
that will make them recognize cancer cells and kill them. We now want to see if we can put a
new gene in these cells that will let the T cells recognize and kill sarcoma cells. The new
gene that we will put in makes an antibody specific for HER2 (Human Epidermal Growth Factor
Receptor 2) that binds to sarcoma cells. In addition it contains CD28, which stimulated T
cells and make them last longer. In other clinical studies using T cells, some investigators
found that giving chemotherapy before the T cell infusion can improve the amount of time the
T cells stay in the body and therefore the effect the T cells can have. Giving chemotherapy
before a T cell infusion is called lymphodepletion since the chemotherapy is specifically
chosen to decrease the number of lymphocytes in the body. Decreasing the number of patient's
lymphocytes first should allow the T cells we infuse to expand and stay longer in your body,
and potentially kill cancer cells more effectively. We will use fludarabine or the
combination of cyclophosphamide and fludarabine as the chemotherapy agents for
lymphodepletion. Cyclophosphamide and fludarabine are the chemotherapy agents most commonly
used for lymphodepletion in immunotherapy clinical trials. The purpose of this study is to
find the largest safe dose of chimeric T cells, and to see whether this therapy might help
patients with sarcoma. Another purpose is to see if it is safe to give HER2-CD28 T cells
after lymphodepleting chemotherapy.
Phase:
Phase 1
Details
Lead Sponsor:
Baylor College of Medicine
Collaborators:
Center for Cell and Gene Therapy, Baylor College of Medicine Texas Children's Hospital The Methodist Hospital Research Institute The Methodist Hospital System