NCT04265963

Brief Summary

There are limited options for treatment of relapse/refractory acute myeloid leukemia (AML). CD123 CAR-T cells may have an attractive and permanent effect on anti-tumor. This study purpose to estimate the safety and efficiency of CD123 CAR-T cells to patients with relapse/refractory AML.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P50-P75 for phase_1 leukemia

Timeline
Completed

Started Sep 2019

Typical duration for phase_1 leukemia

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 12, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

April 18, 2023

Status Verified

March 1, 2023

Enrollment Period

4.3 years

First QC Date

January 31, 2020

Last Update Submit

April 16, 2023

Conditions

LeukemiaLeukemia, MyeloidLeukemia, Myeloid, Acute

Outcome Measures

Primary Outcomes (2)

  • Adverse events that related to treatment

    Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).

    2 years

  • The response rate of CD123 CAR-T treatment in patients with relapse/refractory AML that treatment by CD123 CAR-T cells therapy

    The response rate of CD123 CAR-T treatment will be recorded and assessed according to the National Comprehensive Cancer Network Guideline.

    2 years

Secondary Outcomes (6)

  • Cellular kinetics of CD123 CAR-T in Blood

    2 years

  • Cellular kinetics of CD123 CAR-T in Bone marrow

    2 years

  • Cellular kinetics of CD123 positive cells in Bone marrow

    1 years

  • Duration of Response (DOR) of CD123 CAR-T treatment in patients with refractory/relapsed AML

    2 years

  • Progress-free survival(PFS) of CD123 CAR-T treatment in patients with refractory/relapsed AML

    2 years

  • +1 more secondary outcomes

Study Arms (1)

CD123 CAR-T cells treat

EXPERIMENTAL

Patients will be be treated with CD123 CAR-T cells

Biological: CD123 CAR-T cells

Interventions

CD123 CAR-T cellsBIOLOGICAL

CD123 CAR-T cell therapy

CD123 CAR-T cells treat

Eligibility Criteria

Age2 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Signed written informed consent；
  • Diagnose as Relapsed/Refractory AML, and meet one of the following conditions：
  • With persistent disease after at least two lines of therapy；
  • Relapse to the last line of therapy in 6 months，as known as early recurrence;
  • Relapse to the last line of therapy after 6 months, but refractory to this last line of therapy；
  • Relapse more than once. The definition of relapse: Reappearance of blasts in the blood or bone marrow (\>5%) or in any extramedullary site after a CR (the most common are CNS and testicular leukemia).
  • Evidence for cell membrane CD123 expression;
  • KPS\>60;
  • The expect time of survive is above 3 months;
  • Ages: 2 to 75 years;
  • All genders;
  • The patients that diagnosis as high risks, relapse/refractory or inconformity criteria to other therapy；
  • No serious mental disorders;
  • Left ventricular ejection fraction ≥40%;
  • Sufficient hepatic function defined by ALT/AST\<5 x ULN and bilirubin≤34.2μmol/L;
  • +4 more criteria

You may not qualify if:

  • Previous history of other malignancy;
  • Presence of uncontrolled active infection;
  • Evidence of disorder that need the treatment by glucocorticoids;
  • Active or chronic GVHD；
  • The patients treatment by inhibitor of T cell；
  • Pregnant or breasting-feeding women;
  • Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

920th Hospital of Joint Logistics Support Force

Kunming, Yunnan, China

RECRUITING

MeSH Terms

Conditions

LeukemiaLeukemia, MyeloidLeukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Sanbin Wang, MD

    920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

    PRINCIPAL INVESTIGATOR

  • Cheng Qian, PhD

    Chongqing University Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhi Yang, PhD

CONTACT

86-13206140093yangzhi@precision-biotech.com

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

January 31, 2020

First Posted

February 12, 2020

Study Start

September 1, 2019

Primary Completion

December 31, 2023

Study Completion

July 1, 2024

Last Updated

April 18, 2023

Record last verified: 2023-03

Locations

CN(1)