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Cocktail & Poster Display session

11P - Successful transfer and prolonged persistence of engineered lymphocytes with T-cell receptor targeting NY-ESO-1


06 Mar 2023


Cocktail & Poster Display session


Johnathan Arnon


Annals of Oncology (2023) 8 (1suppl_2): 100900-100900. 10.1016/esmoop/esmoop100900


J. Arnon1, S. Kein2, J. Cohen1, A. Zick1, Y. Zarbiv1, M. Avner1, Y. Halutsi1, P. Stepensky3, B. Avni3, S. Grisariu3, A. Elia4, A. Popovtzer1, C. Cohen5, M. Lotem1

Author affiliations

  • 1 Department Of Oncology, Sharett Institute Of Oncology, Hadassah Medical Center, 91120 - Jerusalem/IL
  • 2 Hadassah Cancer Research Institute, Hadassah Medical Center, P.O.B 1200 - Jerusalem/IL
  • 3 Department Of Bone-marrow Transplant, Hadassah Medical Center, 91120 - Jerusalem/IL
  • 4 Department Of Pathology, Hadassah Medical Center, 91120 - Jerusalem/IL
  • 5 Laboratory Of Tumor And Immunology, Bar-Ilan University - Azrieli Faculty of Medicine, ramat gan/IL


This content is available to ESMO members and event participants.

Abstract 11P


T-cells engineered to express antigen-specific T-cell receptors (TCR) recognize neoantigens derived from intracellular proteins and act against tumors. NY-ESO-1 is a cancer-testis antigen, exclusively re-expressed in cancer cells. Case-series of metastatic cancer patients treated with TCRs targeting NY-ESO-1 show a response rate of 50%. Third generation TCRs have increased stability and affinity in pre-clinical models. We present the results of the first three patients treated with specificity-enhanced third generation TCRs targeting NY-ESO-1, in an initial dose of a phase I-II trial.


We first demonstrated safety, persistence, and efficacy of the novel TCR in murine models. We then treated three patients: A 73-year-old male with choroidal melanoma (CM); A 43-year-old male with synovial sarcoma (SS); A 40-year-old female with triple-negative breast cancer (TNBC). Patients had suffered disease progression after resction of local disease and standard-of-care treatment for metastatic disease. Patients were ECOG 0-1, carriers of HLA-A*02:01 and had positive immunohistochemistry for NY-ESO-1 from tumor tissue. Between June and September 2022 patients underwent lympho-pheresis and T-cells were ex-vivo retrovirally-transduced to express HLA-A*02:01-restricted TCRs targeting NY-ESO-1. Patients underwent lympho-depletion (Cyclophosphamide 250mg/m2 and Fludarabine 25mg/m2 D1-3) and 5 days later received 1*109 engineered TCRs, followed by 3-days of continues IL-2 (18x106IU/24H).


No severe adverse events were observed. Grade 1-2 fever and chills were resolved shortly after IL-2 cessation. At one week after administration, flow cytometry showed 5% to 44% of CD3+ positive lymphocytes in patients’ blood were engineered TCRs and remaining detectable at 30 to 160 days. Best response was stable disease lasting 3 months for the MC and SS patients and progressive disease for the TNBC patient.


This is an initial dose of a first-in-human investigator-initiated trial, using a specificity-enhanced third generation TCR targeting NY-ESO-1. A durable persistence was shown for the modified lymphocytes associated with short-term stabilization of metastatic disease and with acceptable safety.

Clinical trial identification

HBI-0201-ESO TCRT- NCT05296564.

Editorial acknowledgement

Legal entity responsible for the study

Michal Lotem, MD, Hadassah Medical Center.


Dr Miriam and Sheldon G Adelson Medical Research Foundation.


All authors have declared no conflicts of interest.

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