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NCT03674411 · ADVERSE EVENTS

Adverse events

Trial Evaluating MGTA-456 in Patients With High-Risk Malignancy · Source last updated 2026-01-06

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
2 years
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
FLU, CY, TBI + MGTA-456 Infusion

All patients aged 3-55 years will be conditioned with cyclophosphamide (CY) 120 mg/kg total dose, fludarabine (FLU) 75 m/m2 total dose and total body irradiation (TBI) 1320 cGy total dose as well as tacrolimus (Tac) and mycophenolate mofetil (MMF) immunoprophylaxis and granulocyte-colony stimulating factor (G-CSF)

0 / 160 / 165 / 16
BU,FLU, MEL + MGTA-456 Infusion

All young children \<3 years of age at the time of diagnosis will receive MGTA-456 on the day of transplantation after a non-TBI containing myeloablative conditioning as TBI may have a damaging effect on brain development in the very young child. All patients aged 0-3 years will be conditioned with busulfan (BU), FLU and melphalan (MEL) as well as Tac/MMF immunoprophylaxis and G-CSF

0 / 20 / 22 / 2

Group identifiers: EG000: FLU, CY, TBI + MGTA-456 Infusion · EG001: BU,FLU, MEL + MGTA-456 Infusion

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Other reported adverse events

    Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

      Complete source fields
      event Groups
      1. deaths Num Affected
        5
        deaths Num At Risk
        16
        description
        All patients aged 3-55 years will be conditioned with cyclophosphamide (CY) 120 mg/kg total dose, fludarabine (FLU) 75 m/m2 total dose and total body irradiation (TBI) 1320 cGy total dose as well as tacrolimus (Tac) and mycophenolate mofetil (MMF) immunoprophylaxis and granulocyte-colony stimulating factor (G-CSF)
        id
        EG000
        other Num Affected
        0
        other Num At Risk
        16
        serious Num Affected
        0
        serious Num At Risk
        16
        title
        FLU, CY, TBI + MGTA-456 Infusion
      2. deaths Num Affected
        2
        deaths Num At Risk
        2
        description
        All young children \<3 years of age at the time of diagnosis will receive MGTA-456 on the day of transplantation after a non-TBI containing myeloablative conditioning as TBI may have a damaging effect on brain development in the very young child. All patients aged 0-3 years will be conditioned with busulfan (BU), FLU and melphalan (MEL) as well as Tac/MMF immunoprophylaxis and G-CSF
        id
        EG001
        other Num Affected
        0
        other Num At Risk
        2
        serious Num Affected
        0
        serious Num At Risk
        2
        title
        BU,FLU, MEL + MGTA-456 Infusion
      frequency Threshold
      0
      time Frame
      2 years

      Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

      Preserved source evidence · Not medical advice