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NCT04097301 · OUTCOME

Phase I: Hematologic Disease Response to MLM-CAR44.1 T-cells in MM

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
1 and 3 months following T-cell infusion, assessed as day 0

What was measured

Hematologic disease response evaluated at Day 28 following CART-cell infusion, as overall response rate (ORR), stringent complete response (sCR), CR, very good partial response (VGPR) and partial response (PR).

Analysis population: Hematologic disease response of the two treated patients was evaluated at Day 28 following CART-cell infusion. Both patients showed a progressive disease (PD) and no sign of response.

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

No response detected

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLM-CAR44.1 T-cells Infusion2Not reportedNot reportedNot reportedNot reported

Hematologic disease response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MLM-CAR44.1 T-cells Infusion0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      title
      No response detected
    2. measurements
      1. group Id
        OG000
        value
        0
      title
      Hematologic disease response
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    units
    Participants
description
Hematologic disease response evaluated at Day 28 following CART-cell infusion, as overall response rate (ORR), stringent complete response (sCR), CR, very good partial response (VGPR) and partial response (PR).
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
population Description
Hematologic disease response of the two treated patients was evaluated at Day 28 following CART-cell infusion. Both patients showed a progressive disease (PD) and no sign of response.
reporting Status
POSTED
time Frame
1 and 3 months following T-cell infusion, assessed as day 0
title
Phase I: Hematologic Disease Response to MLM-CAR44.1 T-cells in MM
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice