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NCT05011422 · ClinicalTrials.gov registry record · Phase 1
Haploidentical Hematopoietic Stem Cell Transplantation With Ex Vivo TCR Alpha/Beta and CD19 Depletion in Pediatric Hematologic Malignancies
A Phase 1 study of Pediatric Hematologic Malignancies, sponsored by Washington University School of Medicine.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT05011422: Recruiting Phase 1 study of Pediatric Hematologic Malignancies, sponsored by Washington University School of Medicine.
NCT05011422 is a Phase 1 study of Pediatric Hematologic Malignancies that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05011422, a Phase 1 study of Pediatric Hematologic Malignancies, is actively recruiting participants, sponsored by Washington University School of Medicine.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
This single arm pilot phase I study with safety run-in is designed to estimate the safety and efficacy of a familial mismatched or haploidentical hematopoietic stem cell transplantation (haplo-HSCT) using a novel graft modification technique (selective αβ-TCR and CD19 depletion).
Primary Outcome
-Events are death, disease recurrence or progression, and graft failure
Conditions Studied
Interventions
- DEVICE Ex Vivo T-cell receptor alpha-beta and CD19+ Depletion using CliniMACs Plus
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-11-03 |
| Est. Completion | 2029-05-31 |
| Phase | Phase 1 |
What NCT05011422 shows while recruiting
NCT05011422 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 1 condition, with Pediatric Hematologic Malignancies appearing as the primary indexed condition, and to 1 intervention - of which Ex Vivo T-cell receptor alpha-beta and CD19+ Depletion using CliniMACs Plus is the first listed.
NCT05011422 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT05011422 about?
NCT05011422 is a clinical study titled "Haploidentical Hematopoietic Stem Cell Transplantation With Ex Vivo TCR Alpha/Beta and CD19 Depletion in Pediatric Hematologic Malignancies". This single arm pilot phase I study with safety run-in is designed to estimate the safety and efficacy of a familial mismatched or haploidentical hematopoietic stem cell transplantation (haplo-HSCT) using a novel graft modification technique (selective αβ-TCR and CD19 depletion).
What is the current status of trial NCT05011422?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2022-11-03. Estimated completion is 2029-05-31.
What conditions does trial NCT05011422 study?
This clinical trial studies the following conditions: Pediatric Hematologic Malignancies.
What interventions are being tested in trial NCT05011422?
The interventions under investigation include: Ex Vivo T-cell receptor alpha-beta and CD19+ Depletion using CliniMACs Plus (DEVICE).
Who is sponsoring clinical trial NCT05011422?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05011422 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05011422's enrollment target sits among peer trials
50 974th of 2000 higher than 984 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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