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NCT04103879 · ClinicalTrials.gov registry record · Phase 2
US Study of UM171-Expanded CB in Patients With High Risk Leukemia/Myelodysplasia
A Phase 2 study, sponsored by ExCellThera.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT04103879 is a Phase 2 study that has completed, run by ExCellThera. The registered enrollment target is 30 participants.
The verdict
NCT04103879, a Phase 2 study, has completed, sponsored by ExCellThera.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
Cord blood (CB) transplants are an option for patients lacking an HLA identical donor but are hampered by low cell dose, prolonged aplasia and high transplant related mortality. UM171, a novel and potent agonist of hematopoietic stem cell self renewal could solve this major limitation, allowing for CB's important qualities as lower risk of chronic GVHD and relapse to prevail. In a previous trial (NCT02668315), the CB expansion protocol using the ECT-001-CB technology (UM171 molecule) has proven to be technically feasible and safe. UM171 expanded CB was associated with a median neutrophil recovery at day (D)+18 post transplant. Amongst 22 patients who received a single UM171 CB transplant with a median follow-up of 18 months, risk of TRM (5%) and grade 3-4 acute GVHD (10%) were low. There was no moderate-severe chronic GVHD. Thus, overall and progression free survival at 12 months were impressive at 90% and 74%, respectively. The UM171 expansion protocol allowed access to smaller, better HLA matched CBs as \>80% of patients received a 6-7/8 HLA matched CB. Interestingly there were patients with high-risk hematologic malignancies and multiple comorbidities (5 patients who had already failed an allogeneic transplant and 5 patients with refractory/relapsed acute leukemia/aggressive lymphoma). Despite this high risk population, progression was 20% at 12 months. This new study seeks to test a similar strategy in a group of patients with high risk acute leukemia/myelodysplasia.
Interventions
- BIOLOGICAL ECT-001-CB (UM171-Expanded Cord Blood Transplant)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2020-11-13 |
| Est. Completion | 2026-02-28 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04103879
The ClinicalTrials.gov registry entry for NCT04103879 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ExCellThera, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ECT-001-CB (UM171-Expanded Cord Blood Transplant) is the first listed.
NCT04103879 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04103879 about?
NCT04103879 is a clinical study titled "US Study of UM171-Expanded CB in Patients With High Risk Leukemia/Myelodysplasia". Cord blood (CB) transplants are an option for patients lacking an HLA identical donor but are hampered by low cell dose, prolonged aplasia and high transplant related mortality. UM171, a novel and potent agonist of hematopoietic stem cell self renewal could solve this major limitation, allowing for ...
What is the current status of trial NCT04103879?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2020-11-13. Estimated completion is 2026-02-28.
What interventions are being tested in trial NCT04103879?
The interventions under investigation include: ECT-001-CB (UM171-Expanded Cord Blood Transplant) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04103879?
This trial is sponsored by ExCellThera, which has 2 total clinical trials registered on ClinicalTrials.gov.
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