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NCT06078696 · ClinicalTrials.gov registry record · Phase 1
Siplizumab for Sickle Cell Disease Transplant
A Phase 1 study, sponsored by Columbia University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT06078696: Clinical Trial Phase 1 study, sponsored by Columbia University.
NCT06078696 is a Phase 1 study that was terminated before completion, run by Columbia University. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06078696, a Phase 1 study, was terminated before completion, sponsored by Columbia University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
The purpose of this study is to find out whether siplizumab is safe and effective for patients with SCD undergoing an allogeneic transplant and to prevent development of Graft versus Host Disease (GVHD) and graft failure. The main goals of this study are : * To determine if acute GVHD occurs and how severe the acute GVHD is in subjects receiving the study drug * To determine if graft failure occurs in subjects receiving the study drugs In this study, participants will receive 5 infusions of the study drug, siplizumab, while getting a stem cell transplant for SCD. Before siplizumab infusion, participants will be given medications to reduce the risks of allergic reaction to the drug.
Primary Outcome
Failure rate is a safety endpoint. Failure rate is defined as: graft failure (Primary Graft Rejection: Primary graft rejection is defined as the absence of donor cells (% donor cells \< 5%) assessed by bone marrow or peripheral blood chimerism assays by Day 42. Late Graft Rejection: The absence (\<5%) of donor hematopoietic cells in peripheral blood or bone marrow beyond Day 42 in a patient who had initial evidence of hematopoietic recovery with \> 20% donor cells will be considered a late graft
Interventions
- PROCEDURE Exchange Transfusion
- DRUG Siplizumab
- DRUG Cyclophosphamide 50mg
- PROCEDURE Stem Cell Infusion
- PROCEDURE Total Body Irradiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2023-09-28 |
| Est. Completion | 2025-12-11 |
| Phase | Phase 1 |
Why NCT06078696 stopped before completion
NCT06078696 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 5 interventions - of which Exchange Transfusion is the first listed.
NCT06078696 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06078696 about?
NCT06078696 is a clinical study titled "Siplizumab for Sickle Cell Disease Transplant". The purpose of this study is to find out whether siplizumab is safe and effective for patients with SCD undergoing an allogeneic transplant and to prevent development of Graft versus Host Disease (GVHD) and graft failure. The main goals of this study are : * To determine if acute GVHD occurs and ho...
What is the current status of trial NCT06078696?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2023-09-28. Estimated completion is 2025-12-11.
What interventions are being tested in trial NCT06078696?
The interventions under investigation include: Exchange Transfusion (PROCEDURE), Siplizumab (DRUG), Cyclophosphamide 50mg (DRUG), Stem Cell Infusion (PROCEDURE), Total Body Irradiation (PROCEDURE).
Who is sponsoring clinical trial NCT06078696?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06078696's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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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