Autologous T-Cells Expressing a Second Generation CAR for Treatment of T-Cell Malignancies Expressing CD5 Antigen
Status:
Recruiting
Trial end date:
2039-09-01
Target enrollment:
Participant gender:
Summary
Patients eligible for this study have a type of blood cancer called T-cell leukemia or
lymphoma (lymph gland cancer).
The body has different ways of fighting infection and disease. No one way seems perfect for
fighting cancers. This research study combines two different ways of fighting disease,
antibodies and T cells, hoping that they will work together. Antibodies are types of proteins
that protect the body from bacterial and other diseases. T cells, also called T lymphocytes,
are special infection-fighting blood cells that can kill other cells including 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.
T lymphocytes can kill tumor cells but there normally are not enough of them to kill all the
tumor cells. Some researchers have taken T cells from a person's blood, grown more of them in
the laboratory and then given them back to the person. In some patients who have recently had
a bone marrow or stem cell transplant, the number of T cells in their blood may not be enough
to grow in the laboratory. In this situation, T cells may be collected from their previous
transplant donor, who has a similar tissue type.
The antibody used in this study is called anti-CD5. It first came from mice that have
developed immunity to human leukemia. This antibody sticks to T-cell leukemia or lymphoma
cells because of a substance on the outside of these cells called CD5. CD5 antibodies have
been used to treat people with T-cell leukemia and lymphoma. For this study, anti-CD5 has
been changed so that instead of floating free in the blood it is now joined to the T cells.
When an antibody is joined to a T cell in this way it is called a chimeric receptor.
In the laboratory, the investigators have also found that T cells work better if proteins
that stimulate T cells are also added, such as one called CD28. Adding the CD28 makes the
cells grow better and last longer in the body, thus giving the cells a better chance of
killing the leukemia or lymphoma cells.
In this study investigators are going to attach the CD5 chimeric receptor with CD28 added to
it to the patient's T cells or the previous bone marrow transplant donor's T cells. The
investigators will then test how long the cells last. The decision to use the bone marrow
transplant donor's T cells instead of the patient's will be based on 1) whether there is an
available and willing donor and 2) the likelihood of the patient's T cells being able to grow
in the lab. These CD5 chimeric receptor T cells with CD28 are investigational products not
approved by the Food and Drug Administration.
Phase:
Phase 1
Details
Lead Sponsor:
Baylor College of Medicine
Collaborators:
Center for Cell and Gene Therapy, Baylor College of Medicine Houston Methodist Hospital, TX Texas Children's Hospital The Methodist Hospital System