About ICT01

Anti-BTN3A mAb that selectively activates γ9δ2 T cells for IO

ICT01 is a humanized, anti-BTN3A (also known as CD277) monoclonal antibody that selectively activates γ9δ2 T cells, which are responsible for immunosurveillance of malignancy and infections. The three isoforms of BTN3A targeted by ICT01 are overexpressed on many solid tumors (e.g., melanoma, urothelial cell, colorectal, ovarian, pancreatic, and lung cancer) and hematologic malignancies (e.g., leukemia and lymphomas) and also expressed on the surface of innate (e.g., γδ T cells and NK cells) and adaptive immune cells (T cells and B cells). BTN3A is essential for the activation of the anti-tumor immune response of γ9δ2 T cells.

As demonstrated by data presented at past AACR, ASCO, ASH, ESMO and SITC conferences, ICT01 selectively activates circulating γ9δ2 T cells leading to migration of γ9δ2 T cells out of the circulation and into the tumor tissue and triggers a downstream immunological cascade through secretion of pro-inflammatory cytokines, including but not limited to IFNγ and TNFα, further augmenting the anti-tumor immune response. Anti-tumor activity and efficacy of ICT01 have been shown in patients across several cancer indications.

In July 2025, ICT01 was granted Orphan Drug Designation by both the FDA in the United States and the EMA in Europe for the treatment of acute myeloid leukemia (AML).

Mechanism of action

ImCheck Therapeutics published on Oct 20, 2021, the development results of ICT01 in the medical journal Science Translational Medicine in the article “Development of ICT01, a first-in-class, anti-BTN3A antibody for activating Vγ9Vδ2 T cell-mediated anti-tumor immune response”

This publication has been selected by the AACR journal Cancer Immunology Research Deputy and Senior Editors to be featured in the “What We’re Reading” section of the January issue of CIR

EVICTION (EValuation of ICT01 in Immuno-ONcology) Study

ImCheck is conducting EVICTION, a Phase I/IIa, first-in-human, open-label clinical trial to characterize the safety, tolerability and activity of ICT01 as monotherapy and in combination with pembrolizumab in patients with advanced, relapsed/refractory cancer, including both solid tumors and hematologic cancers.

The trial is an international, multicenter study currently enrolling patients at major cancer centers in France, Belgium, Germany, Spain, the UK, and the US.

Part 1 is a basket trial designed to characterize the preliminary safety, tolerability, and pharmacodynamic activity of ICT01 as monotherapy (Group A: solid tumors; Group B: hematologic tumors) and in combination with pembrolizumab (Group C: solid tumors). Group A included bladder, breast, colorectal, gastric, melanoma, ovarian, prostate, and pancreatic cancer patients, Group B included acute myeloid leukemia, acute lymphocytic leukemia, follicular lymphoma, and diffuse large B cell lymphoma patients, and Group C included bladder, head and neck squamous cell carcinoma, melanoma, and non-small cell lung cancer patients. Basket trials are a clinical trial design that allows new drugs to be tested rapidly in a range of indications, providing initial data on multiple parameters that can contribute to an accelerated development timeline.

Part 2 of the trial is a Phase II cohort expansion in selected indications based on Part I of the study with both monotherapy and combination settings. First indications selected for this Phase II part are ovarian cancer and Head and Neck Squamous Cell Carcinoma (HNSCC).

For more information, please refer tohttps://www.clinicaltrials.gov/ct2/show/NCT04243499.

Data presented at SITC Annual Meeting 2024:

Data presented at ASCO Annual Meeting 2024:

Poster: EVICTION study: ICT01, an anti-Butyrophilin 3A monoclonal antibody activating γ9δ2 T cells in combination with pembrolizumab in checkpoint inhibitor refractory melanoma

Data presented at ASH Annual Meeting 2023:

Poster: Evaluation of ICT01, a γ9δ2 T Cell-Activating Monoclonal Antibody, Combined with Venetoclax and Azacitidine in 1L AML (EVICTION Study)

Data presented at ESMO Annual Meeting 2022:

Oral presentation: The Combination of ICT01, a γ9δ2 T cell-activating mAb, plus Pembrolizumab Induces a Broad Antitumor Immune Response and Disease Control in Patients with CPI-Failure Melanoma, NSCLC and Bladder Cancer: EVICTION Trial

Data presented at AACR Annual Meeting 2022:

Poster: ICT01, an anti-butyrophilin 3A targeted mAb activating γ9δ2 T cells, induces immune remodeling of the tumor microenvironment and clinical responses in combination with pembrolizumab in patients with advanced solid tumors who failed prior checkpoint inhibitor therapy: EVICTION Trial

Data presented at SITC Annual Meeting 2021:

Oral presentation at ESMO Annual Meeting 2021:

Coordinated Activation of Antitumor Responses of γ9δ2 and CD8 T Cells by Targeting BTN3A with ICT01 in Patients with Solid Tumors: EVICTION Trial

Oral presentation at AACR Annual Meeting 2021:

Activation of the anti-tumor immune response of γ9δ2 T cells in patients with solid or hematologic malignancies with ICT01, a first-in-class, monoclonal antibody targeting Butyrophilin 3A: The EVICTION study

Posters presented at SITC Annual Meeting 2020:

EVICTION-2 (EValuation of ICT01 in Immuno-ONcology) Study 2

EVICTION-2 is a first-in-human, dose escalation (Part 1) and cohort expansion (Part 2) clinical trial evaluating ICT01 in combination with low dose subcutaneous IL-2. The trial’s objective is to demonstrate the combination’s ability to selectively expand the number of γ9δ2 T cells in patients with solid tumors (prostate, pancreatic, ovarian, or colorectal cancer).

For more information, please refer tohttps://www.clinicaltrials.gov/ct2/show/NCT04243499.

Data presented at SITC Annual Meeting 2023:

Poster: ICT01 plus Low Dose SC IL-2 Produces a Robust Anti-Tumor Immune Activation in Advanced Cancer Patients (EVICTION-2 Study)

Data presented at AACR Annual Meeting 2023:

Poster: First-in-Human Study of ICT01, an Anti-BTN3A Activating Monoclonal Antibody in Combination with Low Dose IL-2 in Patients with Advanced Solid Tumors (EVICTION-2 Study)

Data presented at SITC Annual Meeting 2022:

Poster: Enhancing the Anti-tumor Immunity and Therapeutic Potential of ICT01 a Butyrophilin3A γ9δ2 T Cell-Activating Monoclonal Antibody with Low Dose IL-2 in Patients with Advanced Solid Tumors: The EVICTION-2 Trial

ICT01 Clinical Advisory Board

Marc Bonneville, DVM, PhD
VP in charge of scientific and medical affairs Institut Merieux
Scientific and Medical director, deputy General Manager Fondation Mérieux
Former Director of the INSERM Cancer Research Center Nantes

Richard Buller, MD, PhD
Independent Consultant, Oncology Diagnostic and Drug Development Consulting, LLC
Former VP Oncology Clinical Development, Pfizer

Johann de Bono, MBChB, FRCP, MSc, PhD, FMedSci, FRSB
Regius Professor of Cancer Research
Professor in Experimental Cancer Medicine and Honorary Consultant Medical Oncologist,
Director of the Drug Development Unit & Head of Prostate Cancer Targeted Therapy Group
The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust

Jean Jacques Fournié, PhD
Director of Research exceptional grade senior researcher at the CNRS Cancer Research Center of Toulouse
Former founding Director of Cancer Research Center of Toulouse

Richard D. Lopez, MD
Associate Professor, Division of Hematologic Malignancies & Cellular Therapy Duke University

Patricia LoRusso, MD
Professor of Medicine (Medical Oncology), Associate Center Director for Innovative Medicine at Yale Cancer Center

Aurélien Marabelle, MD, PhD
Clinical Director, Cancer Immunotherapy Program
Director, Translational Research Laboratory in Immunotherapy
Gustave Roussy, Paris

Daniel Olive, MD, PhD
Head of the Cancer Research Center Marseille
Professor of Immunology and Head of the Oncology Research Program at Aix Marseille University
Scientific Founder of ImCheck

Profiles of our Clinical Advisory Board members