CD30 CAR T Cells, Relapsed CD30 Expressing Lymphoma (RELY-30)
Status:
Recruiting
Trial end date:
2036-02-01
Target enrollment:
Participant gender:
Summary
The subject has a type of lymph gland cancer called Lymphoma.
The body has different ways of fighting infection and disease. No single way seems perfect
for fighting cancer. This research study combines two different ways of fighting disease:
antibodies and T cells. 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. Investigators hope
that both will work better together.
Investigators have found from previous research that they can put a new gene into T cells
that will make them recognize cancer cells and kill them. They now want to test whether these
genetically modified T cells given after chemotherapy will be more effective at killing
cancer cells.
The gene that will be put into the T cells makes an antibody called anti-CD30. This antibody
sticks to lymphoma cells because of a substance on the outside of the cells called CD30.
Anti-CD30 antibodies have been used to treat people with lymphoma, but have not been strong
enough to cure most patients.
For this study, the anti-CD30 antibody 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. These CD30 chimeric receptor-activated T cells (CD30.CAR T
cells) seem to kill some of the tumor, but they don't last very long and so their chances of
fighting the cancer are unknown.
Several studies suggest that the infused T cells need room to be able to multiply and grow to
accomplish their functions, and that this may not happen if there are too many other T cells
in circulation. Because of that, doctors may use chemotherapy drugs to decrease the level of
circulating T cells prior to the CD30.CAR T cells infusion. This is called "lymphodepletion".
CD30.CAR T cells have previously been studied in lymphoma patients. What is new for this
study is that lymphodepletion chemotherapy will be administered in patients who are not post
autologous transplant in the hope that it will result in more durable anti-tumor effects.
Phase:
Phase 1
Details
Lead Sponsor:
Baylor College of Medicine
Collaborators:
Texas Children's Hospital The Methodist Hospital Research Institute The Methodist Hospital System