Phase 1/2: CD45RA Depleted Stem Cell Addback to Prevent Viral or Fungal Infections Post TCRab/CD19 Depleted HSCT
Public ClinicalTrials.gov record NCT06839456. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 1/2 Study: CD45RA Depleted Peripheral Stem Cell Addback to Prevent Viral and Fungal Infections Following Alternative Donor TCRab/CD19 Depleted Hematopoietic Stem Cell Transplant
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The major morbidities of allogeneic hematopoietic stem cell transplant (HSCT) using donors that are not human leukocyte antigen (HLA) matched siblings are graft vs host disease (GVHD) and life- threatening infections. T cell receptor alpha beta (TCRαβ) T lymphocyte depletion and CD19+ B lymphocyte depletion of alternative donor hematopoietic stem cell (HSC) grafts is effective in preventing GVHD, but immune reconstitution may be delayed, increasing the risk of infections. The central hypothesis of this study is that an addback of CD45RO memory T lymphocytes, derived from a fraction of the original donor peripheral stem cell product depleted of CD45RA naïve T lymphocytes, will accelerate immune reconstitution and help decrease the risk of infections in TCRab/CD19 depleted PSCT.
Study identification
- NCT ID
- NCT06839456
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 100 participants
Conditions and interventions
Conditions
- Leukemia
- High Risk Acute Lymphoblastic Leukemia
- High Risk Acute Myeloid Leukemia
- Relapse Leukemia
- MDS (Myelodysplastic Syndrome)
- Relapsed Non-Hodgkin Lymphoma
- Acquired Aplastic Anemia
- Inherited BMF Syndrome
- Immunodeficiency
- Primary Immune Regulatory Disorder
- Hemoglobinopathies
- Bone Marrow Failure
- Inborn Errors of Metabolism
- HLH
Interventions
- Phase 1 Dose Level 1 Device
- Phase 1 Dose Level 2 Device
- Phase 1 Dose Level 3 Device
- Phase 2 Maximum Tolerated Dose determined in Phase 1 Device
- Phase 2 Established Dose from prior study, NCT03810196 Device
Device
Eligibility (public fields only)
- Age range
- 1 Month to 25 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 20, 2025
- Primary completion
- Feb 28, 2031
- Completion
- Feb 29, 2032
- Last update posted
- Apr 14, 2026
2025 – 2032
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06839456, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 14, 2026 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06839456 live on ClinicalTrials.gov.