Trial Summary
What is the purpose of this trial?Patients on this study have a type of lymph gland cancer called non-Hodgkin Lymphoma or chronic Lymphocytic Leukemia. Their lymphoma or CLL has come back or has not gone away after treatment. Because there is no standard treatment for the 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.
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 disease: 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 blood cells 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-CD19. This antibody sticks to lymphoma cells because of a substance on the outside of these cells called CD19. CD19 antibodies have been used to treat people with lymphoma and CLL. For this study, the anti-CD19 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 receptor. These chimeric receptor-T cells seem to be able to kill tumors, but they don't last very long and so their chances of fighting the cancer are limited.
Investigators found that T cells work better if they also attach a protein called CD28 to the T cells. This protein makes the T cells more active and survive longer.
Also they found that T cells that are also trained to recognize the virus that causes infectious mononucleosis (called Epstein Barr Virus or EBV) can stay in the blood stream for many years.
These CD19-CD28 chimeric receptor T cells and CD19 chimeric-EBV specific T cells are investigational products not approved by the FDA.
The purpose of this study is to find the biggest dose of chimeric T cells that is safe to administer, to see how long each of the T cell populations (CD19-CD28 and CD19-EBV-specific) last, to assess what the side effects are, and to evaluate whether this therapy might help people with lymphoma or CLL.
Eligibility Criteria
This trial is for people with certain types of blood cancers like non-Hodgkin Lymphoma or chronic Lymphocytic Leukemia that have returned or persisted despite treatment. Participants must be over the worst side effects of past treatments, not on other experimental drugs, and without severe liver, heart, or kidney issues. They should also not be pregnant, free from serious infections like HIV/HBV/HCV/CMV, and willing to use effective birth control.Inclusion Criteria
I have recurring low or intermediate grade B-cell lymphoma or B-CLL, or I can't complete standard therapy.
I haven't received rituximab in the last 8 weeks.
I agree to use effective birth control during and for 3 months after the study.
I have relapsed or refractory intermediate B cell lymphoma and will undergo high dose therapy and a stem cell transplant.
My tumor is CD19 positive.
Both I and my donor (if applicable) have been exposed to the Epstein-Barr virus.
Exclusion Criteria
I do not have an active infection with HIV, hepatitis B, hepatitis C, or CMV.
My tumor is located where it could block my airway if it grows.
Treatment Details
The study tests T cells modified with an anti-CD19 antibody (chimeric receptor-T cells) and a protein CD28 to make them more active against cancer. It also uses T cells trained to fight Epstein-Barr Virus (EBV). The goal is to find the highest safe dose of these chimeric T cells, understand their longevity in the body and side effects, and see if they help treat lymphoma or CLL.
1Treatment groups
Experimental Treatment
Group I: autologous or syngeneic PBTLs and EBV-CTLsExperimental Treatment1 Intervention
The subject will be assigned a dose of CD19-CD28 chimeric receptor T cells at study entry.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Houston Methodist HospitalHouston, TX
Texas Children's HospitalHouston, TX
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Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
Center for Cell and Gene Therapy, Baylor College of MedicineCollaborator
The Methodist Hospital Research InstituteCollaborator