NCT02958384

A Clinical Research of LeY-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: Not accepted

Summary

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

Detailed description

Lewis -Y（LeY） is a difucosylated carbohydrate antigen and although its function is not known, it is expressed on a wide range of malignancies including myeloid malignancies. LeY-targeted CAR-T in myeloid malignancies had been explored and showed good efficiency in the treatment of myeloid malignancies. This trial is designed and conducted to test the safety and effectiveness of LeY-targeted CAR-T.

Conditions

• Myeloid Malignancies

Interventions

Type	Name	Description
BIOLOGICAL	Anti-LeY-CAR-transduced T cells	The first 3 enrolled patients will receive autologous-derived LeY-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: 2016-11-08
• Last updated: 2018-01-23

Locations

1 site across 1 country: China