Evidence map›Paper›PMID 40054461›Full record

ArticleCell reports. Medicine2025

Phase 1 study of IMCnyeso, a T cell receptor bispecific ImmTAC targeting NY-ESO-1-expressing malignancies.

Juanita S Lopez, Mohammed Milhem, Marcus O Butler, Fiona Thistlethwaite, Brian A Van Tine, Sandra P D'Angelo, Melissa L Johnson, Takami Sato, Hendrik-Tobias Arkenau, Ramakrishna Edukulla and 3 more

Registry-linked trialAbstract readClinical Trial, Phase I
In one paragraph

Article in Cell reports. Medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03515551 (A Phase I/II Study of IMCnyeso, HLA- A*0201-Restricted, NY-ESO-1- and LAGE-1A-specific Soluble T Cell Receptor and Anti-CD3 Bispecific Molecule, in HLA-A*0201 Positive Patients With Advanced NY-ESO-1 and/or LAGE - 1A Positive Cancer), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
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.

NCT03515551 phase1 / phase2terminatednot on this map

A Phase I/II Study of IMCnyeso, HLA- A*0201-Restricted, NY-ESO-1- and LAGE-1A-specific Soluble T Cell Receptor and Anti-CD3 Bispecific Molecule, in HLA-A*0201 Positive Patients With Advanced NY-ESO-1 and/or LAGE - 1A Positive Cancer

TypeinterventionalSponsorImmunocore LtdRan2018 to 2021Enrolled29ConditionsSelect Advanced Solid TumorsArmsIMCnyeso
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. Review
  6. Article
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  8. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Juanita S LopezDrug Development Unit, Institute of Cancer Research and the Royal Marsden Hospital, London SW7 3RP, UK. Electronic address: juanita.lopez@icr.ac.uk.
Mohammed MilhemDepartment of Internal Medicine, Division of Hematology/Oncology and BMT, University of Iowa Hospitals and Clinics, Iowa City, IA 52242, USA.
Marcus O ButlerDepartment of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto M5G 2M9, ON, Canada; Departments of Medicine and Immunology, University of Toronto, Toronto M5G 2M9, ON, Canada.
Fiona ThistlethwaiteDivision of Cancer Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester M20 4GJ, UK; Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester M20 4BX, UK.
Brian A Van TineDivision of Oncology, Washington University in St. Louis School of Medicine, St. Louis, MO 63110, USA.
Sandra P D'AngeloDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA; Department of Medicine, Weill Cornell Medical College, New York, NY 10065, USA.
Melissa L JohnsonLung Cancer Research Program, Sarah Cannon Research Institute at Tennessee Oncology, Nashville, TN 37203, USA.
Takami SatoDepartment of Medical Oncology, Sidney Kimmel Comprehensive Cancer Center, Jefferson University, Philadelphia, PA 19107, USA.
Hendrik-Tobias ArkenauPhase-1 Trials Unit, Sarah Cannon Research Institute, UCL Cancer Institute, University College London, London W1G 6AD, UK.
Ramakrishna EdukullaBiometrics, Immunocore, Gaithersburg, MD 20878 USA.
Jason WustnerTranslational Medicine, Immunocore, Conshohocken, PA 19428 USA.
Shannon MarshallClinical Development, Immunocore, Gaithersburg, MD 20878 USA.
Jordi RodonDepartment of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston 77030, TX, USA.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

IMCnyeso, an immune mobilizing monoclonal T cell receptor against cancer (ImmTAC) bispecific (New York esophageal squamous cell carcinoma [NY-ESO]×CD3) T cell engager, targets an NY-ESO-1/L-antigen family member-1 isoform A (LAGE-1A) peptide presented by histocompatibility leukocyte antigen (HLA)-A∗02:01. In this phase 1 study, 28 HLA-A∗02:01+ patients with advanced NY-ESO-1/LAGE-1A-positive advanced tumors (n = 28) receive IMCnyeso weekly intravenously (dose range: 3-300 μg; 7 dose-escalation cohorts). The primary objective is to identify the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D); additional objectives include preliminary anti-tumor activity, pharmacokinetics, immunogenicity, and pharmacodynamic changes. The study was terminated before fully enrolling dose escalation, and the MTD was not identified. There are no treatment-related discontinuations or deaths. The most common adverse events are grade 1/2 cytokine release syndrome and associated symptoms. Cytokine induction and transient lymphocyte count decreases are observed at doses 30-300 μg. At these doses, preliminary efficacy includes mixed response (2 patients) and a median overall survival of 12 months. IMCnyeso is well tolerated and, at doses ≥30 μg, induces pharmacodynamic changes consistent with T cell redirection. This study was registered at ClinicalTrials.gov (NCT03515551).

Indexed as

Antibodies, BispecificAntigens, NeoplasmNeoplasmsReceptors, Antigen, T-CellAdultAgedAged, 80 and overFemaleHumansMaleMaximum Tolerated DoseMembrane ProteinsMiddle AgedT-LymphocytesAntibodies, BispecificAntigens, NeoplasmCTAG1B protein, humanMembrane ProteinsReceptors, Antigen, T-Cellbispecificcancer-testis antigendose escalationImmTACimmunotherapyNY-ESOsolid tumorssynovial sarcomaT cell receptor

Identifiers

PMID40054461
PMCPMC12047507

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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.