Trial · NCT07883330
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| 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. |
| Secondary | Suppression of B-cell and T-cell responses | 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 activity against B cells and T cells. |
| Secondary | Cytokine production by 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 cytokine secretion profile. |
| Secondary | Cytotoxic 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 killing activity. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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