Cell Therapy for High Risk T-Cell Malignancies Using CD7-Specific CAR Expressed On Autologous T Cells (CRIMSON)
This study enrolls patients who have a type of blood cancer called T-cell acute lymphoblastic leukemia or T-cell lymphoma (lymph gland cancer) that has come back or has not gone away after standard treatment. To qualify for the study, tumor screening must indicate that a percentage of the tumor cells express the protein CD7.
The body has different ways of fighting infection and disease. This study combines two different ways of fighting disease with antibodies and T cells. Antibodies are types of proteins that protect the body from bacterial and other diseases. T cells, or 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 cancer; they have shown promise, but have not been strong enough to cure most patients.
T cells 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-CD7. This antibody sticks to T-cell leukemia or lymphoma cell because of a substance on the outside of these cells called CD7. CD7 antibodies have been used to treat people with T-cell leukemia and lymphoma. For this study, anti-CD7 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 add proteins that stimulate T cells, 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 attach the CD7 chimeric receptor with CD28 added to it to T cells. Investigators will then test how long the cells last. These CD7 chimeric receptor T cells with CD28 are investigational products not approved by the Food and Drug Administration.
- 1 to 75 years old
- Diagnosis of recurrent T-cell acute lymphoblastic leukemia (T-ALL), T-cell acute lymphoblastic lymphoma (T-LLy), or T-non-Hodgkin lymphoma and suitable for allogeneic hematopoietic stem cell transplant (HSCT)
- with a suitable donor identified
- willing to proceed to transplant if the CD7.CAR treatment induces complete remission and the patient/donor remain suitable candidates
- Acceptable organ function
Detailed inclusion and exclusion criteria are listed at clinicaltrials.gov.