NCT03585517

Brief Summary

Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD123 Chimeric Antigen Receptor to Patients With CD123+ AML

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2018

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 1, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 13, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

July 21, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

January 19, 2023

Status Verified

July 1, 2018

Enrollment Period

2 years

First QC Date

July 1, 2018

Last Update Submit

January 18, 2023

Conditions

AML

Outcome Measures

Primary Outcomes (1)

  • Occurrence of study related adverse events

    defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2

    2 years

Study Arms (1)

IM23 CART

EXPERIMENTAL

All patients will be treated with fludarabine and cyclophosphamide for 3 days,then,CAR-T cells expressing CD123 CAR will be infused 24-96 hours later.

Drug: IM23

Interventions

IM23DRUG

T Cells Expressing an Anti-CD123 Chimeric Antigen Receptor

IM23 CART

Eligibility Criteria

Age3 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with CD123+ Refractory or Relapsed AML
  • To be aged 3 to 80 years
  • Expression of CD123 in Blast ≥90%
  • ECOG score ≤2
  • Voluntary participation in the clinical trials and sign the informed consent.

You may not qualify if:

  • Intracranial hypertension or unconsciousness
  • Respiratory failure
  • CD19 negative
  • Disseminated intravascular coagulation
  • ALT /AST\>3 x normal value; Creatinine\> 1.5 x normal value; Bilirubin \>2.0 x -normal value
  • Hematosepsis or Uncontrolled active infection
  • Uncontrolled diabetes
  • Abalienation;
  • Patients in pregnancy or breast-feeding period
  • Previously treatment with any gene therapy products
  • Any uncontrolled medical disorders that the researchers consider are not eligible to participate the clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xian Lu

Beijing, China

Location

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

July 1, 2018

First Posted

July 13, 2018

Study Start

July 21, 2018

Primary Completion

August 1, 2020

Study Completion

October 1, 2020

Last Updated

January 19, 2023

Record last verified: 2018-07

Locations

CN(1)