Evidence map›Paper›PMID 38519053›Full record

Trial reportJournal for immunotherapy of cancer2024

Targeting refractory/recurrent neuroblastoma and osteosarcoma with anti-CD3×anti-GD2 bispecific antibody armed T cells.

Maxim Yankelevich, Archana Thakur, Shakeel Modak, Roland Chu, Jeffrey Taub, Alissa Martin, Dana Schalk, Amy Schienshang, Sarah Whitaker, Katie Rea and 5 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIClinical Trial, Phase I
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02173093 (Treatment of Neuroblastoma and GD2-Positive Tumors With Activated T Cells Armed With OKT3 X Humanized 3F8 Bispecific Antibodies), which is not on this map. Cited by 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 1 pooled it
8.9field-weighted citation impact, top 2% 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.

NCT02173093 phase1 / phase2unknown statusnot on this map

Treatment of Neuroblastoma and GD2-Positive Tumors With Activated T Cells Armed With OKT3 X Humanized 3F8 Bispecific Antibodies (GD2Bi): A Phase I/II Study

TypeinterventionalSponsorUniversity of VirginiaRan2014 to 2019Enrolled40ConditionsDisseminated Neuroblastoma, Recurrent NeuroblastomaArmsIL-2, GD2Bi-aATC, GM-CSF, laboratory evaluations of immune responses
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Review
  6. Article
  7. Review
  8. Review
  9. Review
  10. Article
  11. Review
  12. Immunotherapeutic Strategies Targeting GD2-Expressing Malignancies.Advances in experimental medicine and biology · 2026
    Review
  13. Review
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Review
  20. Bispecific Antibodies in Solid Tumors: Advances and Challenges.International journal of molecular sciences · 2025
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 5 institutions in 1 country.

Maxim Yankelevich *St. Christopher's Hospital for Children, Philadelphia, Pennsylvania, USA yankelevic@gmail.com LGL4F@uvahealth.org.ORCID 0000-0002-1403-1399
Archana Thakur *University of Virginia Cancer Center, Charlottesville, Virginia, USA.
Shakeel ModakDepartment of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Roland ChuChildren's Hospital of Michigan, Detroit, Michigan, USA.
Jeffrey TaubChildren's Hospital of Michigan, Detroit, Michigan, USA.
Alissa MartinChildren's Hospital of Michigan, Detroit, Michigan, USA.
Dana SchalkUniversity of Virginia Cancer Center, Charlottesville, Virginia, USA.
Amy SchienshangUniversity of Virginia Cancer Center, Charlottesville, Virginia, USA.
Sarah WhitakerUniversity of Virginia Cancer Center, Charlottesville, Virginia, USA.
Katie ReaUniversity of Virginia Cancer Center, Charlottesville, Virginia, USA.
Daniel W LeeUniversity of Virginia Cancer Center, Charlottesville, Virginia, USA.
Qin LiuWistar Institute, Philadelphia, Pennsylvania, USA.
Anthony F ShieldsKarmanos Cancer Institute, Detroit, Michigan, USA.
Nai-Kong V CheungDepartment of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, New York, USA.ORCID 0000-0001-6323-5171
Lawrence G Lum *University of Virginia Cancer Center, Charlottesville, Virginia, USA yankelevic@gmail.com LGL4F@uvahealth.org.
University of Virginia Cancer CenterChildren's Hospital of Michigan · USMemorial Sloan Kettering Cancer Center · USThe Barbara Ann Karmanos Cancer Institute · USThe Wistar Institute · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
Tumor Microenvironment and MetastasisP30CA010815 · NCI · WISTAR INSTITUTE · PI Aaron Robert Goldman · 1985 to 2026
$75.9M
Women's Oncology Program - WONP30CA044579 · NCI · UNIVERSITY OF VIRGINIA CHARLOTTESVILLE · PI Dina Gould Halme · 1987 to 2026
$72.1M
Tumor Biology and Microenvironment (Program 1)P30CA022453 · NCI · WAYNE STATE UNIVERSITY · PI PAUL M STEMMER · 1985 to 2026
$68.4M
Breast Cancer Treatment with Antibody Targeted T CellsR01CA092344 · NCI · WAYNE STATE UNIVERSITY · PI LUM, LAWRENCE G · 2002 to 2012
$4.6M
Targeting Neuroblastoma with armed T cellsR01CA182526 · NCI · WAYNE STATE UNIVERSITY · PI CHEUNG, NAI-KONG V, LUM, LAWRENCE G · 2014 to 2019
$3.9M
Enhancing neoadjuvant chemotherpay responses with targeted T cellsR01CA140314 · NCI · WAYNE STATE UNIVERSITY · PI BEPLER, GEROLD · 2010 to 2015
$2.5M
NCI NIH HHS P30 CA008748NCI NIH HHS P30 CA010815NCI NIH HHS P30 CA022453NCI NIH HHS P30 CA044579NCI NIH HHS R01 CA092344NCI NIH HHS R01 CA140314NCI NIH HHS R01 CA182526
6 · The paper itself

Abstract

backgroundThe survival benefit observed in children with neuroblastoma (NB) and minimal residual disease who received treatment with anti-GD2 monoclonal antibodies prompted our investigation into the safety and potential clinical benefits of anti-CD3×anti-GD2 bispecific antibody (GD2Bi) armed T cells (GD2BATs). Preclinical studies demonstrated the high cytotoxicity of GD2BATs against GD2+cell lines, leading to the initiation of a phase I/II study in recurrent/refractory patients.

methodsThe 3+3 dose escalation phase I study (NCT02173093) encompassed nine evaluable patients with NB (n=5), osteosarcoma (n=3), and desmoplastic small round cell tumors (n=1). Patients received twice-weekly infusions of GD2BATs at 40, 80, or 160×10

resultsOf the 12 patients enrolled, 9 completed therapy in phase I with no dose-limiting toxicities. Mild and manageable cytokine release syndrome occurred in all patients, presenting as grade 2-3 fevers/chills, headaches, and occasional hypotension up to 72 hours after GD2BAT infusions. GD2-antibody-associated pain was minimal. Median overall survival (OS) for phase I and the limited phase II was 18.0 and 31.2 months, respectively, with a combined OS of 21.1 months. A phase I NB patient had a complete bone marrow response with overall stable disease. In phase II, 10 of 12 patients were evaluable: 1 achieved partial response, and 3 showed clinical benefit with prolonged stable disease. Over 50% of evaluable patients exhibited augmented immune responses to GD2+targets post-GD2BATs, as indicated by interferon-gamma (IFN-γ) EliSpots, Th1 cytokines, and/or chemokines.

conclusionsThis study demonstrated the safety of GD2BATs up to 160×10

Indexed as

Antineoplastic AgentsNeuroblastomaOsteosarcomaAntibodies, MonoclonalChildHumansT-LymphocytesAntibodies, MonoclonalAntineoplastic AgentsAdoptive cell therapy - ACTNeuroblastoma

Identifiers

PMID38519053
PMCPMC10961524
OpenAlexW4393091167

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Registered trials

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.