NCT02937103

A Clinical Research of CD123-Targeted CAR-T in Myeloid Malignancies

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Southwest Hospital, China · Academic / Other
• Sex: All
• Age: 14 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The overall purpose of this study is to explore the therapeutic effect of CD123-targeted chimeric antigen receptor T(CAR-T) cells in the treatment of Myeloid Malignancies.

Detailed description

Great progress has been made in the treatment of relapsed and refractory B cell malignancies with CD19-targeted CAR-T cells. However, for myeloid malignancies, which has higher morbidity, trials of CAR-T is few. CD123 is expressed on most myeloid leukemia cells so it is a ideal target for CAR-T. Some researches have revealed that CD123 is a marker of leukemia stem cells, which indicates that the eradication of CD123+ cells may prevent relapse of leukemia. This trial is designed and conducted to test the safety and effectiveness of CD123-targeted CAR-T.

Conditions

• Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	Anti-CD123-CAR-transduced T cells	The first 3 enrolled patients will receive autologous-derived CD123-targeted CAR-T cells on day 1, 2 and 3 with respective 10%, 30% and 60% of the total expected dosage after receiving lymphodepleting chemotherapy. If the 3 patients don't display severe toxicity,the next patients enrolled will get infused in 2 days with respective 40% and 60% total dosage.

Timeline

• Start date: 2016-10-01
• Primary completion: 2019-10-01
• Completion: 2020-10-01
• First posted: 2016-10-18
• Last updated: 2019-06-25

Locations

1 site across 1 country: China