CD123/CLL1 CAR-T Cells for R/R AML (STPHI_0001)

Phase 2

• Conditions: Relapsed/Refractory AML

• Registration Number: NCT03631576
• Lead Sponsor: Fujian Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-10
• Study First Submitted: 2018-08-13
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-15
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-29
• Last Update Posted: 2020-01-02
• Primary Completion: 2021-08-10
• Study Completion: 2021-08-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Leukemia free survival	1 year

Secondary Outcome Measures

Name	Time	Method
Adverse events that are related to treatment	1 year

Trial Locations

Locations (1)

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China