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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03631576
Other study ID # CART-19-04
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date August 10, 2018
Est. completion date August 10, 2021

Study information

Verified date December 2019
Source Fujian Medical University
Contact Jianda Hu, Prof.M.D.Ph.D
Phone 86-13959169016
Email drjiandahu@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date August 10, 2021
Est. primary completion date August 10, 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 70 Years
Eligibility Inclusion Criteria:

- 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%

Exclusion Criteria:

- Pregnant or lactating females.

- Any co-morbidity precluding the administration of CD123/CLL1 CAR-T Cells.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
CD123/CLL1 CAR-T Cells
CD123/CLL1 CAR-T Cell Therapy

Locations

Country Name City State
China Fujian Medical University Union Hospital Fuzhou Fujian

Sponsors (1)

Lead Sponsor Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Leukemia free survival 1 year
Secondary Adverse events that are related to treatment 1 year
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