Harnessing the Immunosuppressive Leukemic Microenvironment to Engineer T Cells With Enhanced Anti-tumor Functionality

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Conditions studied: Acute Myeloid Leukemia

In brief

This is a monocentric, retrospective and prospective study aimed to underline the potential of T-cell receptor (TCR)-mediated Ab recognition from the post transplant setting in acute myeloid leukemia (AML). The study is based on three key biological concepts: * the essential role of CD4+ T cells in leukemia immunosurveillance, * the impact of human leukocyte antigen (HLA) loss or downregulation on immune escape, * the ability of leukemic cells to remodel the tumor microenvironment and impair T-cell function. By addressing these mechanisms, the study aims to identify novel TCRs and generate next-generation engineered T-cell products with improved anti-leukemic activity. The study will be conducted using samples from healthy donors and patients with AML. The Retrospective part will involve samples collected per standard of care from patients already present in the institutional Hematologic Cancer Biobank, while prospective part will regard the use of samples collected during the study protocol from healthy donor and AML patients. Healthy donor peripheral blood samples will be used to isolate tumor-specific TCRs and generate engineered T cells, whereas bone marrow and peripheral blood samples from AML patients will be used to evaluate the anti-tumor activity of the engineered T cells.

Key facts

Study ID: NCT07743047
Run by: IRCCS San Raffaele
People needed: 65
Starts: 2026-09-01
Expected to finish: 2030-12-31
Last updated by the study team: 2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Age ≥18 years
Written informed consent to the regulation of Hematologic Cancer Biobank (EmaBank) of the San Raffaele Hospital (retrospective patients) and to the present study protocol (prospective patients or hematopoietic stem cell transplant donors harvested in the OSR biobank )
Pregnant or breastfeeding and/or women of childbearing potential are eligible
Diagnosis of AML (for patient participants)
Hematopoietic stem cell transplant donors whose samples are stored in the OSR Biobank
Patients or healthy donor should express the HLA allele(s) of interest

You may not qualify if…

Inability to provide a written informed consent.

Full record on ClinicalTrials.gov

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