At a glance
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Cytokine Induced Memory-like NK Cell Adoptive Therapy for Relapsed AML After Allogeneic Hematopoietic Cell Transplant in Children and Adults
In Brief
A Phase 2 clinical trial evaluating CIML NK Cell Infusion, CD3+ T Cell Product Infusion, and 1 other intervention for Acute Myeloid Leukemia. Completed, enrolled 62 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Day 0 and possible second cycle \> 30 days after the first course
Day -1 and possible second cycle \> 30 days after the first course (Pilot Pediatric/Young Adult Cohort). Day 30 and possible second cycle \>30 days after the first course (Phase 2 Adult Cohort)
On Day -2 or -1