Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02782546 | Cytokine Induced Memory-like NK Cell Adoptive Therapy After Haploidentical Donor Hematopoietic Cell Transplantation | PHASE2 | ACTIVE NOT_RECRUITING | 60 | — | — | Jan 30, 2017 | Feb 13, 2028 | Jun 1, 2026 | 1 | United States |
-LFS is defined as the time from achievement of complete remission (CR) to the time of relapse, death in remission, or last follow-up.
| Arm | Type | Description |
|---|---|---|
| Recipient | EXPERIMENTAL | * Standard of care reduced conditioning regimen on Day -1 * Graft cell infusion on Day 0 * Post-transplant cyclophosphamide on Days +3 and +4 * GvHD prophylaxis with tacrolimus and mycophenolate mofetil (MMF) will start on Day +5. MMF will continue till Day +35 and tacrolimus till Day +180 in the absence of GvHD * G-CSF will start on Day +7 and will continue until neutrophil engraftment as per institutional guidelines * The cytokine-induced memory like natural killer (CIML NK) cells will be infused on Day +7 without a filter or pump, slowly by gravity over at least 15 minutes. * ALT-803 will start approximately 4 hours after the CIML NK cell infusion. ALT-803 will be administered subcutaneously at a dose of 10 mcg/kg subcutaneously beginning Day +7 (on the day of CIML NK cell infusion) and then every 21 days for a total of 4 doses |
| Donor | EXPERIMENTAL | * Donors will receive subcutaneous G-CSF from Day -4 till Day 0 and undergo 20L apheresis per institutional guidelines. * Two consecutive days for collection are allowed in case of the target CD34+ cell dose being less than the target 4 x106/kg-bw from the first day of collection. * On Day +6 (one day before the planned CIML NK cell infusion), peripheral blood mononuclear cells will be collected by a single standard 20-L apheresis over 4-5 hours from the same haploidentical related donor that provided the HCT graft. |
| Name | Type | Description |
|---|---|---|
| Graft cell infusion | PROCEDURE | -Day 0 |
| Tacrolimus | DRUG | -GVHD prophylaxis |
| Mycophenolate mofetil | DRUG | -GVHD prophylaxis |
| G-CSF | DRUG | -Continue until neutrophil engraftment as per institutional guidelines |
| CIML NK cell infusion | PROCEDURE | -Day +7 |
| ALT-803 | DRUG | -Start approximately 4 hours after CIML NK cell infusion |
| Leukapheresis | PROCEDURE | -Day +6 |
Recipient Inclusion Criteria: * Refractory AML without complete remission (CR) after 2 or more cycles of induction therapy (primary induction failure), or AML relapsed after obtaining a CR and failed one or more cycles of re-induction therapy. Standard dose 10-day decitabine (20 mg/m2 daily IV x 10...