NCT07743047Not yet recruiting
Harnessing the Immunosuppressive Leukemic Microenvironment to Engineer T Cells With Enhanced Anti-tumor Functionality
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 65 (estimated)
- First submitted
- 29 Jul 2026
- Start date
- Nov 2026
- Primary completion date
- 1 Dec 2028
- Lead sponsor
- IRCCS San Raffaele
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT07743047
What you commit to
- Study type: Observational
- Planned participants: 65
- From Nov 2026 to the primary completion date, 1 Dec 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 1\. Inability to provide a written informed consent.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.