Journal
SCIENCE TRANSLATIONAL MEDICINE
Volume 6, Issue 224, Pages -Publisher
AMER ASSOC ADVANCEMENT SCIENCE
DOI: 10.1126/scitranslmed.3008226
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Funding
- NCI
- Terry Fox Foundation
- American Society of Hematology-Amos Medical Faculty Development Program
- Alliance for Cancer Gene Therapy
- Mallah Foundation
- Majors Foundation
- Damon Runyon Cancer Research Foundation
- Carson Family Charitable Trust
- William Lawrence and Blanche Hughes Foundation
- Kate's Team
- Mr.William H.Goodwin
- Mrs. Alice Goodwin
- Commonwealth Cancer Foundation for Research and the Experimental Therapeutics Center of MSKCC
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We report on 16 patients with relapsed or refractory B cell acute lymphoblastic leukemia (B-ALL) that we treated with autologous T cells expressing the 19-28z chimeric antigen receptor (CAR) specific to the CD19 antigen. The overall complete response rate was 88%, which allowed us to transition most of these patients to a standard-of-care allogeneic hematopoietic stem cell transplant (allo-SCT). This therapy was as effective in high-risk patients with Philadelphia chromosome-positive (Ph+) disease as in those with relapsed disease after previous allo-SCT. Through systematic analysis of clinical data and serum cytokine levels over the first 21 days after T cell infusion, we have defined diagnostic criteria for a severe cytokine release syndrome (sCRS), with the goal of better identifying the subset of patients who will likely require therapeutic intervention with corticosteroids or interleukin-6 receptor blockade to curb the sCRS. Additionally, we found that serum C-reactive protein, a readily available laboratory study, can serve as a reliable indicator for the severity of the CRS. Together, our data provide strong support for conducting a multicenter phase 2 study to further evaluate 19-28z CAR T cells in B-ALL and a road map for patient management at centers now contemplating the use of CAR T cell therapy.
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