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NCT03068819 · ClinicalTrials.gov registry record · Phase 1
Cytokine Induced Memory-like NK Cell Adoptive Therapy for Relapsed AML After Allogeneic Hematopoietic Cell Transplant
A Phase 1 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 62
- Enrollment target
NCT03068819 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 62 participants.
The verdict
NCT03068819, a Phase 1 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 62 participants
- Enrollment target
Study Summary
Donor Lymphocyte Infusion (DLI) following salvage chemotherapy is the one of the most widely used treatment approaches in patients who relapse after allogeneic hematopoietic cell transplant (allo-HCT). However, the complete remission (CR) rates and long term survival remain very poor in these patients and, therefore, there is an unmet need to develop more effective treatment approaches in patients who relapse after allo-HCT. Based on the initial promising results with our ongoing cytokine-induced memory-like (CIML) natural killer (NK) cell trial, the investigators hypothesize that combining the CIML NK cells with DLI approach will significantly enhance the graft versus leukemia and therefore potentially provide potentially curative therapy for these patients with otherwise extremely poor prognosis. Combining CIML NK cells with the DLI platform will also potentially allow these adoptively transferred cells to persist for longer duration as they should not be rejected by donor T cells as the CIML NK cells are derived from the same donor. The use of CIML NK cells is unlikely to lead to excessive graft versus host disease (GVHD) as previous studies have not been associated with excessive GVHD rates.
Interventions
- PROCEDURE Leukapheresis
- DRUG CIML NK Cell Infusion
- PROCEDURE CD3+ T Cell Product Infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2017-10-23 |
| Est. Completion | 2025-06-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03068819
The ClinicalTrials.gov registry entry for NCT03068819 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Leukapheresis is the first listed.
NCT03068819 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03068819 about?
NCT03068819 is a clinical study titled "Cytokine Induced Memory-like NK Cell Adoptive Therapy for Relapsed AML After Allogeneic Hematopoietic Cell Transplant". Donor Lymphocyte Infusion (DLI) following salvage chemotherapy is the one of the most widely used treatment approaches in patients who relapse after allogeneic hematopoietic cell transplant (allo-HCT). However, the complete remission (CR) rates and long term survival remain very poor in these patien...
What is the current status of trial NCT03068819?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2017-10-23. Estimated completion is 2025-06-15.
What interventions are being tested in trial NCT03068819?
The interventions under investigation include: Leukapheresis (PROCEDURE), CIML NK Cell Infusion (DRUG), CD3+ T Cell Product Infusion (PROCEDURE).
Who is sponsoring clinical trial NCT03068819?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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