Trial · NCT07883330
Unraveling Dynamics and Clinical Impact of Tregs in Allogeneic HSCT With PTCy
NCT07883330, Not yet recruiting, Ciceri Fabio
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Unraveling Dynamics and Clinical Impact of Tregs in Allogeneic HSCT With PTCy. Trials, record NCT07883330. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07883330
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Unraveling Dynamics and Clinical Impact of Tregs in Allogeneic HSCT With PTCy
- NCT number
- NCT07883330
- Status
- Not yet recruiting
- Enrollment
- 70 participants, estimated
- Lead sponsor
- Ciceri Fabio
- Conditions
- HSCT
- First posted
- 2026-10-20
- Last updated
- 2026-10-20
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treg functional activity in peripheral blood and bone marrow | 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. |
| Primary | Single-cell RNA sequencing profile of Treg cells | 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. |
| Primary | T-cell receptor (TCR) repertoire of Treg cells | 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. |
| Primary | Treg phenotype in peripheral blood and bone marrow | 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. |
| Primary | Incidence of acute and chronic GvHD | 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. |
| Primary | Major transplant outcomes | 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. |
| Secondary | Treg expansion after ex vivo culture | 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 expansion under different manufacturing conditions (bead-to-T cell ratio, bead timing, and IL-2 concentration). |
| Secondary | Transduction efficiency of anti-CD19 CAR-Tregs | 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 the frequency of CAR-transduced Tregs obtained under different manufacturing conditions. |
| Secondary | Phenotypic characterization of anti-CD19 CAR-Tregs | 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 frequency and expression of Treg-associated markers (FoxP3, LAP, Helios, CTLA-4, TIM-3 and LAG-3) by flow cytometry. |
| Secondary | Polyclonal suppressive activity of anti-CD19 CAR-Tregs | 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-mediated suppression in polyclonal suppression assays. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07883330
GET https://conductscience.org/api/trials/v1/NCT07883330/registered