Evidence map›Paper›PMID 25317870›Full record

Trial reportThe New England journal of medicine2014

Chimeric antigen receptor T cells for sustained remissions in leukemia.

Shannon L Maude, Noelle Frey, Pamela A Shaw, Richard Aplenc, David M Barrett, Nancy J Bunin, Anne Chew, Vanessa E Gonzalez, Zhaohui Zheng, Simon F Lacey and 9 more

RetractedErratum issued 9 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in The New England journal of medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It has been retracted, and should not be counted. It is linked to 9 registered trials, which are not on this map. Cited by 3,147 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3,147citing papers in PubMed, 2 pooled it
180.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01029366 phase1completednot on this map

Pilot Study of Redirected Autologous T-cells Engineered to Contain Anti-CD19 Attached to TCR and 4-1BB Signaling Domains in Patient With Chemotherapy Resistant or Refractory CD19+ Leukemia and Lymphoma

TypeinterventionalSponsorUniversity of PennsylvaniaRan2010 to 2016Enrolled26ConditionsHematopoietic/Lymphoid Cancer, Adult Acute Lymphoblastic Leukemia in Remission, B-cell Adult Acute Lymphoblastic Leukemia, B-cell Chronic Lymphocytic LeukemiaArmsCART-19
NCT01626495 phase1 / phase2completednot on this map

CHP 959 - A Phase I/IIA Study of Redirected Autologous T Cells Engineered to Contain Anti-CD19 Attached to TCRzeta and 4-1BB Signaling Domains in Patients With Chemotherapy Resistant Or Refractory CD19+ Leukemia and Lymphoma

TypeinterventionalSponsorUniversity of PennsylvaniaRan2011 to 2019Enrolled73ConditionsB Cell Leukemia, B Cell LymphomaArmsCART-19
NCT02644655 phase1 / phase2unknown statusnot on this mapstarted 2015, after this paper: background citation

A Clinical Study Using Autologous T Cell Engineered With Chimeric Antigen Receptor Targeting to CD19(Cluster of Differentiation Antigen 19) in Treating Patients With Recurrent /Refractory B Cell Leukemia

TypeinterventionalSponsorSecond Military Medical UniversityRan2015 to 2017Enrolled20ConditionsRecurrent B-Cell Tumor, Refractory B-Cell TumorArmsCD19-specific chimeric antigen receptor
NCT02822326 phase1unknown statusnot on this mapstarted 2016, after this paper: background citation

CD19-CAR-T2 Cells for Relapse/Refractory CD19 Positive Acute Leukemia-a Phase I Trial

TypeinterventionalSponsorGuangdong Provincial People's HospitalRan2016 to 2019Enrolled30ConditionsAcute LeukemiaArmsCD19-CAR-T2 Cells
NCT04969354 phase1recruitingnot on this mapstarted 2021, after this paper: background citation

Clinical Study of CAIX-targeted CAR-T Cells in the Treatment of Advanced Renal Cell Carcinoma

TypeinterventionalSponsorThe Affiliated Hospital of Xuzhou Medical UniversityRan2021 to 2026Enrolled20ConditionsImmunotherapyArmsCAR-T cell immunotherapy
NCT05054257 phase1recruitingnot on this mapstarted 2021, after this paper: background citation

Safety and Efficacy of Anti-CD19 Chimeric Antigen Receptor-modified Autologous T Cells (CART19) in Patients with Relapsed/refractory CD19+ Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma. a Dose Escalation, Open-label, Phase I Study.

TypeinterventionalSponsorInstitute of Hematology and Blood Transfusion, Czech RepublicRan2021 to 2025Enrolled10ConditionsRelapsed or Refractory B-cell Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma Refractory, Non-Hodgkin's Lymphoma, RelapsedArmsAutologous CAR19 T lymphocytes
NCT06471673 phase1 / phase2recruitingnot on this mapstarted 2024, after this paper: background citation

A Study of BRIA-OTS Cellular Immunotherapy in Metastatic Recurrent Breast Cancer

TypeinterventionalSponsorBriaCell Therapeutics CorporationRan2024 to 2025Enrolled18ConditionsBreast Cancer, Breast Tumor, Cancer of Breast, Cancer of the BreastArmsBC1 cell line, Bria-OTS regimen and CPI (tislelizumab), Bria-OTS regimen and CPI (tislelizumab) expansion cohort
NCT06503094 phase1 / phase2unknown statusnot on this mapstarted 2024, after this paper: background citation

The Safety and Efficacy of CD19 & CD20 Bispecific CAR T Cells in Treating Relapsed / Refractory B Cell Hematological Tumors

TypeinterventionalSponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRan2024 to 2026Enrolled80ConditionsB-Cell Lymphoblastic Leukemia/LymphomaArmsCD19&CD20 bispecific CAR-T cells
NCT07502118 phase2 / phase3recruitingnot on this mapstarted 2025, after this paper: background citation

An Open-Label, Multicenter Phase 2-3 Clinical Study of Anti-CD19 Chimeric Antigen Receptor T Cells (Talikabtagene Autoleucel) in Patients With Relapsed/Refractory B-Cell Malignancies (NexCAR19)

TypeinterventionalSponsorHealth Institutes of TurkeyRan2025 to 2030Enrolled40ConditionsRelapsed/Refractory B-cell Acute Lymphoblastic Leukemia (B-ALL), Relapsed/Refractory Non-Hodgkin Lymphoma, Diffuse Large B-Cell Lymphoma (DLBCL), High-grade B-cell Lymphoma (HGBCL)ArmsTalikabtagene Autoleucel
3 · Its place in the literature

Who cites it

3,147 citing papers in PubMed, 2 syntheses or guidelines pooled it, 5,325 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Trial
  4. Trial
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  7. Trial
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  12. Review
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  19. Review
  20. FOXP1 Knockdown Reprograms Th9 CAR-T Cells to Overcome Antigen Escape.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026
    Article

3,087 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 2 institutions in 1 country.

Shannon L MaudeFrom the Division of Oncology, Children's Hospital of Philadelphia (S.L.M., R.A., D.M.B., N.J.B., S.R.R., D.T.T., S.A.G.), the Departments of Pediatrics (S.L.M., R.A., D.M.B., N.J.B., S.R.R., D.T.T., S.A.G.), Biostatistics and Epidemiology (P.A.S., R.A.), and Pathology and Laboratory Medicine (J.J.M., B.L.L., C.H.J., S.A.G.), the Division of Hematology-Oncology (N.F., D.L.P.), and Abramson Cancer Center (N.F., A.C., V.E.G., Z.Z., S.F.L., Y.D.M., J.J.M., B.L.L., C.H.J., D.L.P., S.A.G.), Perelman School of Medicine, University of Pennsylvania - all in Philadelphia; and Novartis Pharmaceuticals, East Hanover, NJ (A.S.).
Noelle Frey
Pamela A Shaw
Richard Aplenc
David M Barrett
Nancy J Bunin
Anne Chew
Vanessa E Gonzalez
Zhaohui Zheng
Simon F Lacey
Yolanda D Mahnke
Jan J Melenhorst
Susan R Rheingold
Angela Shen
David T Teachey
Bruce L Levine
Carl H June
David L Porter
Stephan A Grupp
University of Pennsylvania · USChildren's Hospital of Philadelphia · US

Funding

UNIVERSITY OF PENNSYLVANIA CAN CTR SUPPORT GRANTP30CA016520 · NCI · UNIVERSITY OF PENNSYLVANIA · PI SHELLEY L BERGER · 1985 to 2026
$222.3M
Virus & Reservoirs CoreP30AI045008 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI ROBERT GROSS · 1999 to 2026
$78.6M
CANCER RESEARCH TRAINING PROGRAMT32CA009615 · NCI · UNIVERSITY OF PENNSYLVANIA · PI Gregory L Beatty, MICHAEL D HOGARTY · 1988 to 2026
$10.4M
CD19 Directed CAR TherapyR01CA165206 · NCI · UNIVERSITY OF PENNSYLVANIA · PI JUNE, CARL H., PORTER, DAVID L · 2012 to 2016
$2.2M
Abramson Cancer Center Support GrantP30CA147859 · NCI · UNIVERSITY OF PENNSYLVANIA · PI LERMAN, CARYN · 2009 to 2010
$1.6M
USE OF mTOR INHIBITORS IN B CELL LEUKEMIAR01CA102646 · NCI · CHILDREN'S HOSP OF PHILADELPHIA · PI GRUPP, STEPHAN A. · 2005 to 2009
$1.6M
Determinants of Relapse Risk After BMT for ALLR01CA116660 · NCI · CHILDREN'S HOSP OF PHILADELPHIA · PI GRUPP, STEPHAN A. · 2007 to 2011
$1.5M
NCI NIH HHS 1R01CA165206NCI NIH HHS P30 CA016520NCI NIH HHS P30 CA147859NCI NIH HHS R01 CA102646NCI NIH HHS R01CA102646NCI NIH HHS R01 CA116660NCI NIH HHS R01CA116660NCI NIH HHS R01 CA165206NCI NIH HHS T32 CA009615NIAID NIH HHS P30 AI045008
6 · The paper itself

Abstract

backgroundRelapsed 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.

methodsWe 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.

resultsA 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.

conclusionsChimeric 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.).

Indexed as

Antigens, CD19Genetic TherapyImmunotherapyAdolescentAdultAntibodies, Monoclonal, HumanizedChildChild, PreschoolChimeraCytokinesFemaleGenetic EngineeringGenetic VectorsHumansLentivirusMaleAntibodies, Monoclonal, HumanizedAntigens, CD19CytokinesReceptors, Antigen, T-Celltocilizumab

Identifiers

PMID25317870
PMCPMC4267531
OpenAlexW2118796952

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.