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NCT06986382 · ClinicalTrials.gov registry record · Phase 1
Phase 1b/2a Trial of Allogeneic HSCT From an HLA-partially Matched Related or Unrelated Donor After TCRab+ T-cell/CD19+ B-cell Depletion for Patients With Monogenic and/or Early-onset Medically Refractory Crohn Disease
A Phase 1 study, sponsored by Stanford University.
- Not yet
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT06986382: Clinical Trial Phase 1 study, sponsored by Stanford University.
NCT06986382 is a Phase 1 study that has not yet begun recruiting, run by Stanford University. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06986382, a Phase 1 study, has not yet begun recruiting, sponsored by Stanford University.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
This research study is investigating whether alpha beta T-cell depleted hematopoietic stem cell transplant (HSCT) can be an immune system replacement for Crohn disease patients and whether this is safe and effective for patients with early onset, medically refractory Crohn disease.
Primary Outcome
Cumulative incidence of donor myeloid engraftment by Day +42 post-HSCT. Myeloid engraftment is defined as ANC of \> 0.5 x 109/L for three consecutive laboratory values obtained on different days. Date of myeloid engraftment is the first date of the three lab values taken.
Interventions
- DRUG Palifermin
- DRUG ATG
- DRUG Clofarabine
- DEVICE CliniMACS® TCR α/β Reagent Kit and CliniMACS® CD19 System
- DRUG Prednisone/Methylprenisolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2025-07 |
| Est. Completion | 2040-07 |
| Phase | Phase 1 |
What is known before NCT06986382 opens enrollment
NCT06986382 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 5 interventions - of which Palifermin is the first listed.
NCT06986382 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06986382 about?
NCT06986382 is a clinical study titled "Phase 1b/2a Trial of Allogeneic HSCT From an HLA-partially Matched Related or Unrelated Donor After TCRab+ T-cell/CD19+ B-cell Depletion for Patients With Monogenic and/or Early-onset Medically Refractory Crohn Disease". This research study is investigating whether alpha beta T-cell depleted hematopoietic stem cell transplant (HSCT) can be an immune system replacement for Crohn disease patients and whether this is safe and effective for patients with early onset, medically refractory Crohn disease.
What is the current status of trial NCT06986382?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2025-07. Estimated completion is 2040-07.
What interventions are being tested in trial NCT06986382?
The interventions under investigation include: Palifermin (DRUG), ATG (DRUG), Clofarabine (DRUG), CliniMACS® TCR α/β Reagent Kit and CliniMACS® CD19 System (DEVICE), Prednisone/Methylprenisolone (DRUG).
Who is sponsoring clinical trial NCT06986382?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06986382's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 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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