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NCT06731504 · ClinicalTrials.gov registry record · Early Phase 1
HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT
A Early Phase 1 study of Hematologic Malignancy, sponsored by Duke University.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT06731504 is a Early Phase 1 study of Hematologic Malignancy that is actively recruiting participants, run by Duke University. The registered enrollment target is 10 participants, below the 228-participant average among 48 other Hematologic Malignancy trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06731504, a Early Phase 1 study of Hematologic Malignancy, is actively recruiting participants, sponsored by Duke University.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is a single-center, non-randomized, single-arm pilot trial of omidubicel hematopoietic stem cell transplantation (HCT) for hematologic malignancies with myeloablative conditioning chemotherapy of physician's choice followed by abatacept/tacrolimus/mycophenolate mofetil (ABA/Tac/MMF) graft-versus-host disease (GVHD) prophylaxis. The primary objective is to assess the safety and feasibility of abatacept/tacrolimus/mycophenolate mofetil GVHD prophylaxis following omidubicel HCT. Target enrollment is 10 participants. Subjects are adults with a diagnosis of hematologic malignancy with an available cord blood unit for omidubicel product manufacturing. Patients will be followed for a total of 18 months and will have research blood draws and Abatacept pharmacokinetics, as well as standard of care assessments that will be reviewed for this study. It is estimated that 36 months of accrual will be necessary to enroll the targeted sample size with an accrual rate of approximately 1 participant every 3 months. Accrual will be reported by race, ethnicity, gender, and age. Descriptive analyses are planned given the sample size.
Conditions Studied
Interventions
- DRUG Abatacept
Study Locations (1)
North Carolina
- Duke University Health System - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2025-11-12 |
| Est. Completion | 2028-07 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06731504
The ClinicalTrials.gov registry entry for NCT06731504 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 228-participant average among 48 other Hematologic Malignancy trials with a reported enrollment target (96% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hematologic Malignancy appearing as the primary indexed condition, and to 1 intervention - of which Abatacept is the first listed.
NCT06731504 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT06731504 about?
NCT06731504 is a clinical study titled "HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT". This study is a single-center, non-randomized, single-arm pilot trial of omidubicel hematopoietic stem cell transplantation (HCT) for hematologic malignancies with myeloablative conditioning chemotherapy of physician's choice followed by abatacept/tacrolimus/mycophenolate mofetil (ABA/Tac/MMF) graft...
What is the current status of trial NCT06731504?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2025-11-12. Estimated completion is 2028-07.
What conditions does trial NCT06731504 study?
This clinical trial studies the following conditions: Hematologic Malignancy.
What interventions are being tested in trial NCT06731504?
The interventions under investigation include: Abatacept (DRUG).
Who is sponsoring clinical trial NCT06731504?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06731504 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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