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NCT04097301 · OUTCOME

Phase IIa: Hematologic Disease Response in AML

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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
1, 2 and 6 months after MLM-CAR44.1 T-cell infusion, assessed as day 0.

What was measured

The hematologic disease response will be classified with the following response criteria: complete response (CR), incomplete response (CRi) and partial response (PR) according to ELN criteria.

Analysis population: Data were not collected because Phase IIa was not performed due to early end of trial

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 Infusion0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
The hematologic disease response will be classified with the following response criteria: complete response (CR), incomplete response (CRi) and partial response (PR) according to ELN criteria.
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
population Description
Data were not collected because Phase IIa was not performed due to early end of trial
reporting Status
POSTED
time Frame
1, 2 and 6 months after MLM-CAR44.1 T-cell infusion, assessed as day 0.
title
Phase IIa: Hematologic Disease Response in AML
type
SECONDARY

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

Preserved source evidence · Not medical advice