An observational study in HSCT, sponsored by Ciceri Fabio. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Ciceri Fabio · Observational
This prospective and retrospective, observational, monocentric study aims to investigate the longitudinal dynamics, phenotype, and functional properties of regulatory T cells (Tregs) in patients affected by hematological malignancies undergoing allogeneic hematopoietic stem cell transplantation (HSCT) with post-transplant cyclophosphamide (PTCy)-based GvHD prophylaxis. Peripheral blood and bone marrow samples will be collected according to clinical practice at predefined timepoints and correlated with major transplant outcomes, including graft-versus-host disease (GvHD), relapse and graft-versus-tumor (GvT), infections, and inflammatory complications.
The study hypothesis is that quantitative and functional alterations of Tregs after HSCT influence immune tolerance, GvHD occurrence, and graft-versus-tumor activity, and that the characterization of Treg dysfunction may support the development of innovative CAR-Treg-based immunotherapeutic strategies to control GvHD and preserve GvT. This is a prospective and retrospective, observational, biological, monocenter study. The retrospective component will consist of a cohort of patients with previously biobanked biological samples, collected between 2013 and September 2026, which will serve as a control group for the laboratory analyses.
Ciceri Fabio is the lead sponsor of 8 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
We will include 70 female and male adult patients affected by hematological malignancies, candidates for allogeneic HSCT with a GvHD prophylaxis regimen based on post-transplant cyclophosphamide (PTCy) and sirolimus. Furthermore, the study design includes a retrospective cohort (around 10 patients) aimed at selecting the biological samples that will serve as controls for the laboratory analyses.
Participant with hematological undergoing :
Healthy Participant (as control cohort):
Participant with systemic diseases (as control cohort):
Exclusion Criteria:
Participant with hematological malignancies undergoing HSCT:
Healthy Participant and Participant with systemic autoimmune diseases (as control cohort):
-Pediatric population (individuals aged \<18 years)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
We will include 70 female and male adult patients affected by hematological malignancies, candidates for allogeneic HSCT with a GvHD prophylaxis regimen based on post-transplant cyclophosphamide (PTCy) and sirolimus.Furthermore, the study design includes a retrospective cohort (around 10 patients) aimed at selecting the biological samples that will serve as controls for the laboratory analyses.
Treg functional activity in peripheral blood and bone marrow
Assessment of Treg suppressive function through functional assays at baseline, day +15, month 1, month 3, month 6, month 12 after HSCT, at disease relapse, and at GvHD onset.
Time frame: Baseline (prior to HSCT); +15 days after HSCT; + 1 month after HSCT; + 3 months after HSCT; + 6 months after HSCT; + 1 year after HSCT; disease relapse; GvHD onset (acute and/or chronic).
Single-cell RNA sequencing profile of Treg cells
Characterization of Treg transcriptional profiles by single-cell RNA sequencing at baseline, day +15, month 1, month 3, month 6, month 12 after HSCT, at disease relapse, and at GvHD onset.
Time frame: Baseline (prior to HSCT); +15 days after HSCT; + 1 month after HSCT; + 3 months after HSCT; + 6 months after HSCT; + 1 year after HSCT; disease relapse; GvHD onset (acute and/or chronic).
T-cell receptor (TCR) repertoire of Treg cells
Characterization of Treg clonality and TCR repertoire by single-cell TCR sequencing at baseline, day +15, month 1, month 3, month 6, month 12 after HSCT, at disease relapse, and at GvHD onset.
Time frame: Baseline (prior to HSCT); +15 days after HSCT; + 1 month after HSCT; + 3 months after HSCT; + 6 months after HSCT; + 1 year after HSCT; disease relapse; GvHD onset (acute and/or chronic).
Treg phenotype in peripheral blood and bone marrow
Assessment of regulatory T-cell (Treg) phenotypic characteristics by flow cytometry at baseline, day +15, month 1, month 3, month 6, month 12 after HSCT, at disease relapse, and at GvHD onset.
Time frame: Baseline (prior to HSCT); +15 days after HSCT; + 1 month after HSCT; + 3 months after HSCT; + 6 months after HSCT; + 1 year after HSCT; disease relapse; GvHD onset (acute and/or chronic).
Incidence of acute and chronic GvHD
Occurrence of acute and/or chronic GvHD during follow-up after HSCT.
Time frame: Baseline (prior to HSCT); +15 days after HSCT; + 1 month after HSCT; + 3 months after HSCT; + 6 months after HSCT; + 1 year after HSCT; disease relapse; GvHD onset (acute and/or chronic).
Major transplant outcomes
Assessment of major transplant outcomes, including overall survival, relapse, non-relapse mortality, and graft failure, during follow-up.
Time frame: Baseline (prior to HSCT); +15 days after HSCT; + 1 month after HSCT; + 3 months after HSCT; + 6 months after HSCT; + 1 year after HSCT; disease relapse; GvHD onset (acute and/or chronic).
Treg expansion after ex vivo culture
Assessment of Treg expansion under different manufacturing conditions (bead-to-T cell ratio, bead timing, and IL-2 concentration).
Time frame: Baseline (prior to HSCT); +15 days after HSCT; + 1 month after HSCT; + 3 months after HSCT; + 6 months after HSCT; + 1 year after HSCT; disease relapse; GvHD onset (acute and/or chronic).
Transduction efficiency of anti-CD19 CAR-Tregs
Assessment of the frequency of CAR-transduced Tregs obtained under different manufacturing conditions.
Time frame: Baseline (prior to HSCT); +15 days after HSCT; + 1 month after HSCT; + 3 months after HSCT; + 6 months after HSCT; + 1 year after HSCT; disease relapse; GvHD onset (acute and/or chronic).
Phenotypic characterization of anti-CD19 CAR-Tregs
Assessment of Treg frequency and expression of Treg-associated markers (FoxP3, LAP, Helios, CTLA-4, TIM-3 and LAG-3) by flow cytometry.
Time frame: Baseline (prior to HSCT); +15 days after HSCT; + 1 month after HSCT; + 3 months after HSCT; + 6 months after HSCT; + 1 year after HSCT; disease relapse; GvHD onset (acute and/or chronic).
Polyclonal suppressive activity of anti-CD19 CAR-Tregs
Assessment of Treg-mediated suppression in polyclonal suppression assays.
Time frame: Baseline (prior to HSCT); +15 days after HSCT; + 1 month after HSCT; + 3 months after HSCT; + 6 months after HSCT; + 1 year after HSCT; disease relapse; GvHD onset (acute and/or chronic).
Suppression of B-cell and T-cell responses
Assessment of Treg suppressive activity against B cells and T cells.
Time frame: Baseline (prior to HSCT); +15 days after HSCT; + 1 month after HSCT; + 3 months after HSCT; + 6 months after HSCT; + 1 year after HSCT; disease relapse; GvHD onset (acute and/or chronic).
Cytokine production by anti-CD19 CAR-Tregs
Assessment of cytokine secretion profile.
Time frame: Baseline (prior to HSCT); +15 days after HSCT; + 1 month after HSCT; + 3 months after HSCT; + 6 months after HSCT; + 1 year after HSCT; disease relapse; GvHD onset (acute and/or chronic).
Cytotoxic activity of anti-CD19 CAR-Tregs
Assessment of Treg-mediated killing activity.
Time frame: Baseline (prior to HSCT); +15 days after HSCT; + 1 month after HSCT; + 3 months after HSCT; + 6 months after HSCT; + 1 year after HSCT; disease relapse; GvHD onset (acute and/or chronic).
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Apr 2029, 29 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Ciceri Fabio