Phase I Study of UCART123 in Patient With Adverse Genetic Risk Acute Myeloid Leukemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-11

Study Completion Date

2019-12-05

Brief Summary

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This is a Phase I, open-label, dose escalation study of UCART123 administered intravenously to patients with newly diagnosed CD123 positive adverse genetic risk acute myeloid leukaemia (AML) defined in the ELN adverse genetic risk group (2017). The purpose of this study is to evaluate the safety and clinical activity of multiple infusions of UCART123 and to determine the Maximum Tolerated Dose (MTD).

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Detailed Description

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Conditions

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Acute Myeloid Leukaemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose escalation

Several tested doses of UCART123 until the Maximum Tolerated Dose (MTD) is identified.

Group Type EXPERIMENTAL

UCART123

Intervention Type BIOLOGICAL

Allogeneic engineered T-cells expressing anti-CD123 Chimeric Antigen Receptor

Interventions

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UCART123

Allogeneic engineered T-cells expressing anti-CD123 Chimeric Antigen Receptor

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patients newly diagnosed with CD123 positive adverse genetic risk acute myeloid leukaemia (AML) defined as per ELN guidelines (Döhner et al., 2017)
* Eastern Cooperative Oncology Group performance status of 0 or 1
* No prior gene or experimental cellular therapy
* No organ dysfunction that in the opinion of the investigator precludes intensive induction chemotherapy or cellular therapy

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No