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NCT04097301 · FLOW

Participant flow

Study of CAR T-cell Therapy in Acute Myeloid Leukemia and Multiple Myeloma · Source last updated 2022-01-19

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

groups
  1. description
    Patients were scheduled to receive a single intravenous (iv) infusion of CD44v6.CAR-transduced autologous lymphocytes at day 0, after lymphodepleting chemotherapy with cyclophosphamide iv (500 mg/m2) and fludarabine iv (30 mg/m2) performed daily from day -5 to day -3 The dose of iv infused MLM-CAR44.1 T-cells is: PHASE I: 0.5x10E6/Kg or 1x10E6/Kg or 2x10E6/Kg according to the BOIN design. PHASE IIa: a dose of MLM-CAR44.1 T-cells corresponding to the maximum tolerated dose (MTD).
    id
    FG000
    title
    MLM-CAR44.1 T-cells Infusion
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Screening Failure
    milestones
    1. achievements
      1. comment
        Enrolled patients. Overall, 8 patients were enrolled in the study and underwent the screening phase to evaluate the compliance to the clinical inclusion / exclusion criteria as well as the CD44v6 expression by tumor cells.
        group Id
        FG000
        num Subjects
        8
      type
      STARTED
    2. achievements
      1. comment
        Of the 8 enrolled patients, 2 were treated with MLM-CAR44.1 T-cell at the first dose level.
        group Id
        FG000
        num Subjects
        2
      type
      Treated Patients
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        7
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The recruited patient population, due to the early termination of the clinical study, was made up only of patients affected by multiple myeloma (MM), whereas AML patients were not enrolled. Eight patients, 6 males and 2 females were enrolled in 2 centers. Two patients received the investigational product (MLM-CAR44.1 T-cells), while 6 patients did not. Age ranged from 41 to 66 years, with a median of 56 years.
recruitment Details
The study population originally planned is made up of: Adult patients 18 to 75 years old or 18 to 63 years old for CZ site, with relapsed/refractory AML or MM expressing CD44v6; Children 1 to 17 years old with AML, only in Phase IIa, except for CZ site. Up to the early termination of the study only adult patients 18 to 75 years old or 18 to 63 years old for CZ site, with relapsed/refractory MM expressing CD44v6 were recruited
Complete source fields
groups
  1. description
    Patients were scheduled to receive a single intravenous (iv) infusion of CD44v6.CAR-transduced autologous lymphocytes at day 0, after lymphodepleting chemotherapy with cyclophosphamide iv (500 mg/m2) and fludarabine iv (30 mg/m2) performed daily from day -5 to day -3 The dose of iv infused MLM-CAR44.1 T-cells is: PHASE I: 0.5x10E6/Kg or 1x10E6/Kg or 2x10E6/Kg according to the BOIN design. PHASE IIa: a dose of MLM-CAR44.1 T-cells corresponding to the maximum tolerated dose (MTD).
    id
    FG000
    title
    MLM-CAR44.1 T-cells Infusion
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Screening Failure
    milestones
    1. achievements
      1. comment
        Enrolled patients. Overall, 8 patients were enrolled in the study and underwent the screening phase to evaluate the compliance to the clinical inclusion / exclusion criteria as well as the CD44v6 expression by tumor cells.
        group Id
        FG000
        num Subjects
        8
      type
      STARTED
    2. achievements
      1. comment
        Of the 8 enrolled patients, 2 were treated with MLM-CAR44.1 T-cell at the first dose level.
        group Id
        FG000
        num Subjects
        2
      type
      Treated Patients
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        7
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The recruited patient population, due to the early termination of the clinical study, was made up only of patients affected by multiple myeloma (MM), whereas AML patients were not enrolled. Eight patients, 6 males and 2 females were enrolled in 2 centers. Two patients received the investigational product (MLM-CAR44.1 T-cells), while 6 patients did not. Age ranged from 41 to 66 years, with a median of 56 years.
recruitment Details
The study population originally planned is made up of: Adult patients 18 to 75 years old or 18 to 63 years old for CZ site, with relapsed/refractory AML or MM expressing CD44v6; Children 1 to 17 years old with AML, only in Phase IIa, except for CZ site. Up to the early termination of the study only adult patients 18 to 75 years old or 18 to 63 years old for CZ site, with relapsed/refractory MM expressing CD44v6 were recruited

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Preserved source evidence · Not medical advice