Chimeric Antigen Receptor (CAR)
T-cell Trial for Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
Note: This study has reached the target number of patients to be treated, and accrual for the trial is currently closed.
Relapsed acute lymphoblastic
leukemia, or relapsed ALL, refers to the return of acute lymphoblastic leukemia (ALL) in patients who have already undergone treatment for the disease.
Between 15 and 20 percent of children who are treated for ALL and achieve an
initial complete remission will have the disease return (relapse) at some
gene therapy clinical trial for relapsed B-cell ALL is testing the safety of
giving patients immune-cancer-fighting cells that are created from their own
blood; these are called “modified T-cells.” The goal is to find a safe dose of
modified T-cells for patients whose leukemia has returned.
CAR T-cell therapy is a promising
option for patients with leukemia for several reasons:
Patients with recurrent leukemia in their bone marrow may have
defective T-cells that are less able to kill leukemia cells. By genetically
modifying T-cells so that they target the B-cell-specific antigen CD 19 (which
is almost always expressed by B-ALL cells), they may be able to better
recognize and kill leukemia cells. The concept is to utilize genetic
engineering to “re-direct” T-cells to this antigen and also provide additional
genetic information to the cell that allows it to better respond to the tumor
itself. The genetic engineering is accomplished using a DNA shuttle (or
vehicle) to insert new DNA information into the T-cells in a highly specialized
laboratory (called a GMP laboratory).
who meet the following criteria may be eligible to take part in this relapsed
ALL gene therapy clinical trial:
Patients also must NOT have the following: