Project Term
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Project Summary
This proposal examines the use of CD19-directed chimeric antigen receptor (CD19-CAR) T cell immunotherapy to treat adults aged 55 years or older who have acute lymphoblastic leukemia (ALL) that is in remission following induction therapy (i.e., “first remission”). In this clinical trial, we will infuse the CD19-CAR T cells early in the treatment sequence, which may prevent the leukemia from returning without additional therapy. This clinical trial aims to give us a better understanding of CD19-CAR T cell safety and activity when given during first remission, with the goal of improving the very poor outcomes of older adults with ALL.
Lay Abstract
Older adults with acute lymphoblastic leukemia (ALL) have limited treatment options and a poor prognosis. Chimeric antigen receptor (CAR) T cell therapy targeting CD19 (CD19-CAR T cells) is a powerful form of immunotherapy that uses a patient’s own immune system to kill their leukemia. Currently, CD19-CAR T cells are approved by the Food and Drug Administration to treat adults who have initially responded to other therapies but then their leukemia returned (“relapsed”). In this setting, CD19-CAR T cells are safe and active, but patients may require additional therapy such as bone marrow transplant for long-term cure. Older adults with relapsed ALL may be unable to tolerate additional therapy such as bone marrow transplant due to their age or illness. To improve the outcomes of older adults with ALL, we propose to use CD19-CAR T cells earlier in the course of treatment. We hypothesize that treating patients with ALL that is in remission following initial therapy (“first remission”) will be safe and induce long-term cure without the need for additional therapy. In this clinical trial, we will treat adults 55 years or older who have ALL that is in first remission with a single dose of CD19-CAR T cells. We will make each patient their own CD19-CAR T cells using the manufacturing platform that we previously developed and determined to be safe and effective in a separate clinical trial in adults with relapsed ALL. The goal of this clinical trial is to evaluate the safety and determine the best dose of CD19-CAR T cells in older adults in first remission. We will also evaluate how well CD19-CAR T cells work when patients are in remission by measuring how often patients relapse and how long they live after treatment, as well as how long CD19-CAR T cells stay in the patient’s blood after treatment. Lastly, we will describe the development of frailty in older patients following CD19-CAR T cell therapy by evaluating quality of life measures, including both physical and mental measures of health. Moving CD19-CAR T cell therapy earlier in the course of treatment has the potential to minimize both the number of cancer therapies and ultimately the duration of therapy in older adults with ALL, which will contribute to overall quality of life in these patients. Therefore, successful completion of this clinical trial has the potential to be practice changing for the treatment of older adults with ALL.
Program
