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NCT04097301 · OUTCOME

Phase I: The Levels of Circulating MLM-CAR44.1 T-cells in Blood Samples

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
At day 7, 14, 21, 28, 60, 90, 180 from infusion, assessed as day 0

What was measured

The levels will be evaluated by flow cytometry and qPCR (in vivo pharmacokinetic profile).

Groups in this outcome

MLM-CAR44.1 T-cells Infusion

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).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
MLM-CAR44.1 T-cells Infusion2

Reported measurements

Source class 1

Positive at day 14 and 21

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLM-CAR44.1 T-cells Infusion1Not reportedNot reportedNot reportedNot reported

Negative at all monitoring time points

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLM-CAR44.1 T-cells Infusion1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      title
      Positive at day 14 and 21
    2. measurements
      1. group Id
        OG000
        value
        1
      title
      Negative at all monitoring time points
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    units
    Participants
description
The levels will be evaluated by flow cytometry and qPCR (in vivo pharmacokinetic profile).
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
    OG000
    title
    MLM-CAR44.1 T-cells Infusion
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
At day 7, 14, 21, 28, 60, 90, 180 from infusion, assessed as day 0
title
Phase I: The Levels of Circulating MLM-CAR44.1 T-cells in Blood Samples
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice