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NCT07015684 · ClinicalTrials.gov registry record · Phase 1
131I-apamistamab-based Conditioning for Hematopoietic Stem Cell Transplant (HSCT) in Advanced Sickle Cell Disease (SCD)
A Phase 1 study of Sickling Disorder Due to Hemoglobin S, sponsored by Columbia University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT07015684: Recruiting Phase 1 study of Sickling Disorder Due to Hemoglobin S, sponsored by Columbia University.
NCT07015684 is a Phase 1 study of Sickling Disorder Due to Hemoglobin S that is actively recruiting participants, run by Columbia University. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07015684, a Phase 1 study of Sickling Disorder Due to Hemoglobin S, is actively recruiting participants, sponsored by Columbia University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to find the smallest amount of the 131 I-apamistamab needed for preparing patients with severe sickle cell disease (SCD) for a bone marrow transplant. This is the first time 131 I-apamistamab is being used for advanced Sickle Cell Disease (SCD) in the setting of allogeneic stem cell transplant. 131 I-apamistamab is an investigational product. This means that 131 I-apamistamab has not been approved by the Food and Drug Administration (FDA) for medical use in patients. The study treatment that is given before the transplant is called the conditioning regimen. In this study, the investigators are adding a drug called 131 I-apamistamab instead of the conditioning regimen typically given before a stem cell transplant.
Primary Outcome
Graft failure defined as having had a primary or secondary graft failure by 42 days after blood stem cell (PB) transplantation. Primary graft failure is defined as failure to achieve an absolute neutrophil count (ANC) of \>500/ μL by 42 days after blood stem cell (PB) transplantation or a total donor chimerism of \>5%. Secondary graft failure is defined as cytopenias after initial engraftment (ANC \<500/μL) and a total donor cell chimerism decreasing to less than 5%.
Conditions Studied
Interventions
- DRUG Sirolimus
- DRUG 131I-apamistmab
- DRUG Campath
- DRUG Total Body Irradiation
- PROCEDURE Exchange Transfusion
Study Locations (1)
New York
- Columbia University Irving Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2025-04-28 |
| Est. Completion | 2032-03-12 |
| Phase | Phase 1 |
What NCT07015684 shows while recruiting
NCT07015684 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 1 condition, with Sickling Disorder Due to Hemoglobin S appearing as the primary indexed condition, and to 5 interventions - of which Sirolimus is the first listed.
NCT07015684 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT07015684 about?
NCT07015684 is a clinical study titled "131I-apamistamab-based Conditioning for Hematopoietic Stem Cell Transplant (HSCT) in Advanced Sickle Cell Disease (SCD)". The purpose of this study is to find the smallest amount of the 131 I-apamistamab needed for preparing patients with severe sickle cell disease (SCD) for a bone marrow transplant. This is the first time 131 I-apamistamab is being used for advanced Sickle Cell Disease (SCD) in the setting of allogene...
What is the current status of trial NCT07015684?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2025-04-28. Estimated completion is 2032-03-12.
What conditions does trial NCT07015684 study?
This clinical trial studies the following conditions: Sickling Disorder Due to Hemoglobin S.
What interventions are being tested in trial NCT07015684?
The interventions under investigation include: Sirolimus (DRUG), 131I-apamistmab (DRUG), Campath (DRUG), Total Body Irradiation (DRUG), Exchange Transfusion (PROCEDURE).
Who is sponsoring clinical trial NCT07015684?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07015684 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07015684's enrollment target sits among peer trials
24 1521st of 2000 higher than 405 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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