Cited by 5,413CAR-T cell therapy researchAcute Lymphoblastic Leukemia researchImmunotherapy and Immune Responses

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Chimeric Antigen Receptor T Cells for Sustained Remissions in Leukemia

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Maude, Shannon L., Frey, Noelle, Shaw, Pamela A., Aplenc, Richard, Barrett, David M., Bunin, Nancy J., Chew, Anne, Gonzalez, Vanessa E., Zheng, Zhaohui, Lacey, Simon F., Mahnke, Yolanda D., Melenhorst, Jan J., Rheingold, Susan R., Shen, Angela, Teachey, David T., Levine, Bruce L., June, Carl H., Porter, David L., Grupp, Stephan A.·2014·New England Journal of Medicine

DOI 10.1056/nejmoa1407222PMC PMC4267531

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Abstract

BACKGROUND: Relapsed acute lymphoblastic leukemia (ALL) is difficult to treat despite the availability of aggressive therapies. Chimeric antigen receptor-modified T cells targeting CD19 may overcome many limitations of conventional therapies and induce remission in patients with refractory disease. METHODS: We infused autologous T cells transduced with a CD19-directed chimeric antigen receptor (CTL019) lentiviral vector in patients with relapsed or refractory ALL at doses of 0.76×10(6) to 20.6×10(6) CTL019 cells per kilogram of body weight. Patients were monitored for a response, toxic effects, and the expansion and persistence of circulating CTL019 T cells. RESULTS: A total of 30 children and adults received CTL019. Complete remission was achieved in 27 patients (90%), including 2 patients with blinatumomab-refractory disease and 15 who had undergone stem-cell transplantation. CTL019 cells proliferated in vivo and were detectable in the blood, bone marrow, and cerebrospinal fluid of patients who had a response. Sustained remission was achieved with a 6-month event-free survival rate of 67% (95% confidence interval [CI], 51 to 88) and an overall survival rate of 78% (95% CI, 65 to 95). At 6 months, the probability that a patient would have persistence of CTL019 was 68% (95% CI, 50 to 92) and the probability that a patient would have relapse-free B-cell aplasia was 73% (95% CI, 57 to 94). All the patients had the cytokine-release syndrome. Severe cytokine-release syndrome, which developed in 27% of the patients, was associated with a higher disease burden before infusion and was effectively treated with the anti-interleukin-6 receptor antibody tocilizumab. CONCLUSIONS: Chimeric antigen receptor-modified T-cell therapy against CD19 was effective in treating relapsed and refractory ALL. CTL019 was associated with a high remission rate, even among patients for whom stem-cell transplantation had failed, and durable remissions up to 24 months were observed. (Funded by Novartis and others; CART19 ClinicalTrials.gov numbers, NCT01626495 and NCT01029366.).

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BackgroundResult
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BackgroundInfluential
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Background
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Background
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Background
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Background
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“15, 18, 36 The FDA recently approved tocilizumab”
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Method
Fundamentals of T Cell Metabolism and Strategies to Enhance Cancer Immunotherapy
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Self-citation
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“B cells, effective CD19 CAR-T cell therapy will be accompanied by B cell aplasia, which can be managed by the periodic administration of intravenous immunoglobulin (IVIG).(2,4,6,9,12,15,45)”
Background
Next-generation cell therapies: the emerging role of CAR-NK cells
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“High-grade CRS and ICANS require hospitalization in intensive care and occur in up to 50% of recipients of CAR T cells 2,3 .”
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CAR-T Cell Therapy for Acute Lymphoblastic Leukemia: Transforming the Treatment of Relapsed and Refractory Disease
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IL-6 Revisited: From Rheumatoid Arthritis to CAR T Cell Therapy and COVID-19
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A Novel Anti-LILRB4 CAR-T Cell for the Treatment of Monocytic AML
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Anti-CD37 chimeric antigen receptor T cells are active against B- and T-cell lymphomas
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Co-Stimulatory Receptor Signaling in CAR-T Cells
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“of the infused product, with circulating CAR-T cells detectable 12–24 months after infusion [49,50,52,196,197].”
Background
Tumor-intrinsic sensitivity to the pro-apoptotic effects of IFN-γ is a major determinant of CD4+ CAR T-cell antitumor activity
Boulch, M., Cazaux, M., Cuffel, A., Guérin, M. V., Garcia, Z., Alonso, R., Lemaı̂tre, F., Beer, A., Corre, B., Menger, L., et al. (2023) · Nature Cancer · doi:10.1038/s43018-023-00570-7 · Cited by 143
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Self-citation
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Tisagenlecleucel Model‐Based Cellular Kinetic Analysis of Chimeric Antigen Receptor–T Cells
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Self-citation
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“For patients with refractory or relapsed acute lymphoblastic leukemia (ALL) who were treated with engineered CD8 T cells retrovirally transduced with anti-CD19 CAR constructs, over 90% remission rate was achieved (30).”
Background
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Scattered seeding of CAR T cells in solid tumors augments anticancer efficacy
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Background
Inotuzumab ozogamicin in adults with relapsed or refractory CD22-positive acute lymphoblastic leukemia: a phase 1/2 study
DeAngelo, D. J., Stock, W., Stein, A. S., Shustov, A. R., Liedtke, M., Schiffer, C. A., Vandendries, E. R., Liau, K., Ananthakrishnan, R., Boni, J. P., et al. (2017) · Blood Advances · doi:10.1182/bloodadvances.2016001925 · Cited by 137
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Self-citation
Purification of mRNA Encoding Chimeric Antigen Receptor Is Critical for Generation of a Robust T-Cell Response
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Self-citation
Natural Killer Cells and Current Applications of Chimeric Antigen Receptor-Modified NK-92 Cells in Tumor Immunotherapy
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In the Eye of the Storm: Immune‐mediated Toxicities Associated With CAR‐T Cell Therapy
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“Early studies already reported that CAR-T cells could be detected in the CSF after infusion and expansion.(50,53,89) A significant correlation with ICANS could just be found in one of these studies which showed higher levels of CAR-T cells in CSF in patients who developed ICANS when compared to patients without neurol…”
BackgroundResultInfluential
Epitope base editing CD45 in hematopoietic cells enables universal blood cancer immune therapy
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Cooney, A. L., McCray, P. B., & Sinn, P. L. (2018) · Genes · doi:10.3390/genes9110538 · Cited by 138
Use of a Single CAR T Cell and Several Bispecific Adapters Facilitates Eradication of Multiple Antigenically Different Solid Tumors
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Self-citation

Authors: Maude, S. L., Frey, N., Shaw, P. A., Aplenc, R., Barrett, D. M., Bunin, N. J., Chew, A., Gonzalez, V. E., Zheng, Z., Lacey, S. F., Mahnke, Y. D., Melenhorst, J. J., Rheingold, S. R., Shen, A., Teachey, D. T., Levine, B. L., June, C. H., Porter, D. L., & Grupp, S. A.
Affiliations: Children's Hospital of Philadelphia (US)
Abramson Cancer Center (US)
University of Pennsylvania (US)
ORCID: Maude, Shannon L.
Frey, Noelle
Shaw, Pamela A.
Aplenc, Richard
Barrett, David M.
Bunin, Nancy J.
Gonzalez, Vanessa E.
Zheng, Zhaohui
Lacey, Simon F.
Mahnke, Yolanda D.
Melenhorst, Jan J.
Rheingold, Susan R.
Shen, Angela
Teachey, David T.
Levine, Bruce L.
June, Carl H.
Porter, David L.
Grupp, Stephan A.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2014-10-16
Volume: 371
Issue: 16
Pages: 1507-1517
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1407222
PMC: PMC4267531
OpenAlex: W2118796952
Cited by: 5,413
References: 30
Citations by year: 2026: 228 · 2025: 318 · 2024: 378 · 2023: 505 · 2022: 495 · 2021: 558 · 2020: 665 · 2019: 538 · 2018: 501 · 2017: 541 · 2016: 385 · 2015: 261 · 2014: 24
FWCI: 195.01
Type: journal article
Language: en
Update notices: correction (2016-03-10)
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
Funders: Children's Hospital of Philadelphia
St. Jude Children's Research Hospital
School of Medicine, Indiana University
National Cancer Institute (P30CA147859, R01CA165206, R01CA102646, R01CA116660, T32CA009615, P30CA016520)
National Institute of Allergy and Infectious Diseases (P30AI045008)
Topics: Health Sciences › Medicine › Oncology › CAR-T cell therapy research
Health Sciences › Medicine › Hematology › Acute Lymphoblastic Leukemia research
Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
Keywords: chimeric antigen receptor T cells, CD19, acute lymphoblastic leukemia, relapsed/refractory leukemia, CAR T-cell therapy, tisagenlecleucel, lentiviral vectors, complete remission, cytokine release syndrome, tocilizumab, B-cell aplasia, stem cell transplantation, event-free survival, sustained remission, pediatric and adult patients
MeSH terms: Adolescent, Adult, Child, Child, Preschool, Chimera, Female, Genetic Engineering, Genetic Vectors, Humans, Immunotherapy, Male, Middle Aged, Receptors, Antigen, T-Cell, Recurrence, Remission Induction, T-Lymphocytes, Genetic Therapy, Survival Rate, Lentivirus, Cytokines, Antigens, CD19, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Young Adult, Antibodies, Monoclonal, Humanized

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Chimeric Antigen Receptor T Cells for Sustained Remissions in Leukemia

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