HSCTOSR_ReCARmuneNCT07883330
Unraveling Dynamics and Clinical Impact of Tregs in Allogeneic HSCT With PTCy
An observational study of HSCT, run by Ciceri Fabio at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HSCT
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2026to 1 Nov 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
None listed.
Who cannot join
- Participant with hematological malignancies undergoing HSCT:
- Patients that did not accept to sign the informed consent
- Contraindications to HSCT procedures (including pregnancy and breast feeding) as per standard of care
- Healthy Participant and Participant with systemic autoimmune diseases (as control cohort):
- -Pediatric population (individuals aged <18 years)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
IRCCS Ospedale San Raffale
Milan, Milano, 20132
Raffaella Greco, 02 2643 9396, greco.raffaella@hsr.it
About this study
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.
- Conditions
- HSCT
- Keywords
- HSCT, regulatory T cells, post-transplant cyclophosphamide (PTCy)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients affected by hematological malignancies, candidates for allogeneic HSCT | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Secondary outcomes (7)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HSCTStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ciceri Fabio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ciceri Fabio, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883330
- Sponsor's protocol ID
- OSR_ReCARmune
- Acronym
- OSR_ReCARmune
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unraveling Dynamics and Clinical Impact of Tregs in Allogeneic HSCT With PTCy
- ClinicalTrials.gov ID
- NCT07883330
- Acronym / sponsor ID
- OSR_ReCARmune / OSR_ReCARmune
- Conditions
- HSCT
- Keywords
- HSCT, regulatory T cells, post-transplant cyclophosphamide (PTCy)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ciceri FabioUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Nov 2031 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients affected by hematological malignancies, candidates for allogeneic HSCT | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Patients that did not accept to sign the informed consent
- Contraindications to HSCT procedures (including pregnancy and breast feeding) as per standard of care
- Healthy Participant and Participant with systemic autoimmune diseases (as control cohort):
- -Pediatric population (individuals aged <18 years)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treg functional activity in peripheral blood and bone marrow
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).
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.
Single-cell RNA sequencing profile of Treg 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).
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.
T-cell receptor (TCR) repertoire of Treg 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).
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.
Treg phenotype in peripheral blood and bone marrow
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).
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.
Incidence of acute and chronic GvHD
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).
Occurrence of acute and/or chronic GvHD during follow-up after HSCT.
Major transplant outcomes
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).
Assessment of major transplant outcomes, including overall survival, relapse, non-relapse mortality, and graft failure, during follow-up.
7 secondary outcomes
Treg expansion after ex vivo culture
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
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
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
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
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
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
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HSCT, run by Ciceri Fabio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raffaella Greco MD (02 2643 9396, greco.raffaella@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treg functional activity in peripheral blood and bone marrow (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).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.