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NCT06839456 · ClinicalTrials.gov registry record · Phase 1
Phase 1/2: CD45RA Depleted Stem Cell Addback to Prevent Viral or Fungal Infections Post TCRab/CD19 Depleted HSCT
A Phase 1 study of Leukemia and Relapsed Non-Hodgkin Lymphoma, sponsored by Children's Hospital of Philadelphia.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT06839456: Recruiting Phase 1 study of Leukemia and Relapsed Non-Hodgkin Lymphoma, sponsored by Children's Hospital of Philadelphia.
NCT06839456 is a Phase 1 study of Leukemia and Relapsed Non-Hodgkin Lymphoma that is actively recruiting participants, run by Children's Hospital of Philadelphia. The registered enrollment target is 100 participants, below the 486-participant average among 233 other Leukemia trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06839456, a Phase 1 study of Leukemia and Relapsed Non-Hodgkin Lymphoma, is actively recruiting participants, sponsored by Children's Hospital of Philadelphia.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Safety evaluation assessment by cumulative incidence of acute graft vs host disease (reaction of donor immune cells against host tissues) to determine percentage of patients that develop grade 3-4 aGVHD.
Conditions Studied
Interventions
- DEVICE 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
Study Locations (1)
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-03-21 |
| Est. Completion | 2032-03 |
| Phase | Phase 1 |
What NCT06839456 shows while recruiting
NCT06839456 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 486-participant average among 233 other Leukemia trials with a reported enrollment target (79% lower).
The record links to 10 conditions, with Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Phase 1 Dose Level 1 is the first listed.
NCT06839456 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06839456 about?
NCT06839456 is a clinical study titled "Phase 1/2: CD45RA Depleted Stem Cell Addback to Prevent Viral or Fungal Infections Post TCRab/CD19 Depleted HSCT". 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 d...
What is the current status of trial NCT06839456?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2025-03-21. Estimated completion is 2032-03.
What conditions does trial NCT06839456 study?
This clinical trial studies the following conditions: Leukemia, Relapsed Non-Hodgkin Lymphoma, MDS (Myelodysplastic Syndrome), Immunodeficiency, High Risk Acute Myeloid Leukemia.
What interventions are being tested in trial NCT06839456?
The interventions under investigation include: 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).
Who is sponsoring clinical trial NCT06839456?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06839456 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06839456's enrollment target sits among peer trials
100 59th of 233 higher than 170 of 233 other Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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