NCT03631576

Brief Summary

The treatment options for relapse/refractory B-cell acute myeloid leukemia(AML)are limited.CD123/CLL1 CAR-T Cells may have a permanent anti-tumor effect and became very attractive. This study aims to assess the safety and toxicity of CD123/CLL1 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
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2018

Typical duration for phase_2

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

August 10, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2021

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

3 years

First QC Date

August 13, 2018

Last Update Submit

December 29, 2019

Conditions

Relapsed/Refractory AML

Outcome Measures

Primary Outcomes (1)

  • Leukemia free survival

    1 year

Secondary Outcomes (1)

  • Adverse events that are related to treatment

    1 year

Study Arms (1)

Arm 1

EXPERIMENTAL

CD123/CLL1 CAR-T Cells treat

Biological: CD123/CLL1 CAR-T Cells

Interventions

CD123/CLL1 CAR-T CellsBIOLOGICAL

CD123/CLL1 CAR-T Cell Therapy

Arm 1

Eligibility Criteria

AgeUp to 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Signed written informed consent
  • Aged \< 70 years
  • Patients with relapsed/refractory AML
  • Cardiac: Left ventricular ejection fraction ≥ 50%
  • Adequate renal and hepatic function
  • Performance status: Karnofsky ≥ 70%

You may not qualify if:

  • Pregnant or lactating females.
  • Any co-morbidity precluding the administration of CD123/CLL1 CAR-T Cells.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Jianda Hu, Prof.M.D.Ph.D

CONTACT

86-13959169016drjiandahu@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the department of Hematology

Study Record Dates

First Submitted

August 13, 2018

First Posted

August 15, 2018

Study Start

August 10, 2018

Primary Completion

August 10, 2021

Study Completion

August 10, 2021

Last Updated

January 2, 2020

Record last verified: 2019-12

Locations

CN(1)