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Mycophenolate mofetil · 1 trial · 1 indication
-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...
Mycophenolate mofetil is being studied as part of a Phase 2 clinical trial for Acute Myeloid Leukemia (AML). The trial combines cytokine-induced memory-like NK cell adoptive therapy after haploidentical donor hematopoietic cell transplantation. It is an investigational small molecule in development by ImmunityBio, Inc. for this oncology indication.
Mycophenolate mofetil is a small molecule, but its specific molecular target is not disclosed in the available information. It is being evaluated in a Phase 2 trial for Acute Myeloid Leukemia, where it is used in combination with cytokine-induced memory-like NK cell adoptive therapy after haploidentical donor hematopoietic cell transplantation.
Mycophenolate mofetil is being developed by ImmunityBio, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol IBRX. The company is conducting a Phase 2 clinical trial for this drug in Acute Myeloid Leukemia.
Mycophenolate mofetil is in Phase 2 clinical development for Acute Myeloid Leukemia. It is an investigational drug and has not been approved by regulatory authorities. The ongoing trial is active but not recruiting participants, with a planned enrollment of 60 patients.
Mycophenolate mofetil is being studied in the clinical trial NCT02782546, titled 'Cytokine Induced Memory-like NK Cell Adoptive Therapy After Haploidentical Donor Hematopoietic Cell Transplantation.' This Phase 2 trial is active but not recruiting, enrolling 60 adults with Acute Myeloid Leukemia in the United States.