Not Yet RecruitingNot Applicable

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

65 participantsStarted 2026-09-01

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Identification and functional characterization of novel tumor-specific TCRs

Timeframe: From study initiation through month 24

Trial details

NCT IDNCT07743047

SponsorIRCCS San Raffaele

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-12-01

View on ClinicalTrials.gov More Acute Myeloid Leukemia trials