NCT04106076

Brief Summary

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).

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2019

Shorter than P25 for phase_1

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 11, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2019

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

5 months

First QC Date

September 25, 2019

Last Update Submit

July 13, 2020

Conditions

Acute Myeloid Leukaemia

Keywords

Acute Myeloid LeukaemiaNewly diagnosed AMLELN adverse genetic risk groupChimeric Antigen Receptor T-Cell (CAR-T) therapyAllogeneicTranscription Activator-Like Effector Nuclease (TALEN)

Outcome Measures

Primary Outcomes (1)

  • Incidence of AE/SAE/DLT [Safety and Tolerability]

    Incidence, nature, and severity of adverse events and serious adverse events (SAEs) throughout the study

    24 months

Study Arms (1)

Dose escalation

EXPERIMENTAL

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

Biological: UCART123

Interventions

UCART123BIOLOGICAL

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

Dose escalation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Ghulam Mufti, Pr

    Kings college London NHS Foundation Trust

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2019

First Posted

September 26, 2019

Study Start

July 11, 2019

Primary Completion

December 5, 2019

Study Completion

December 5, 2019

Last Updated

July 14, 2020

Record last verified: 2020-07