CD19 Chimeric Receptor Expressing T Lymphocytes In B-Cell Non Hodgkin's Lymphoma, ALL & CLL
Status:
Active, not recruiting
Trial end date:
2029-07-01
Target enrollment:
Participant gender:
Summary
Patients on this study have a type of lymph gland cancer called non-Hodgkin Lymphoma, Acute
Lymphocytic Leukemia, or chronic Lymphocytic Leukemia (these diseases will be referred to as
"Lymphoma" or "Leukemia"). Their Lymphoma or Leukemia has come back or has not gone away
after treatment (including the best treatment known for these cancers). This research study
is a gene transfer study using special immune cells.
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.
The antibody used in this study is called anti-CD19. It first came from mice that have
developed immunity to human lymphoma. This antibody sticks to cancer cells because of a
substance on the outside of these cells called CD19. CD19 antibodies have been used to treat
people with lymphoma and Leukemia. For this study anti-CD19 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, investigators have also found that T cells work better if they also put a
protein that stimulates T cells called CD28. Investigators hope that adding the CD28 might
also make the cells last for a longer time in the body.
These CD19 chimeric receptor T cells with C28 T cells are investigational products not
approved by the Food and Drug Administration.
The purpose of this study is to find the biggest dose of chimeric T cells that is safe, to
see how the T cell with this sort of chimeric receptor lasts, to learn what the side effects
are and to see whether this therapy might help people with lymphoma or leukemia.
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