NCT05913804

YTS104 Cell Injection for the Treatment of Relapsed or Refractory Multiple Myeloma

An Exploratory Clinical Study on the Safety and Efficacy of YTS104 Cell Injection in the Treatment of Relapsed or Refractory Multiple Myeloma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, single-arm, open-label phase I clinical study to determine the safety and efficacy of relapsed or refractory multiple myeloma subjects

Detailed description

This study will recruit multiple myeloma subjects,and Subjects should undergo FC chemotherapy before returning the cells, then followed by infusion of YTS104 cells injection. YTS104 cells injection will be intravenously infused with a escalated dose of 1E6#3E6#6E6#1E7 cells/kg.

Conditions

• Relapsed or Refractory Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	YTS104 Cells injection	YTS104 Cell injection(LILRB4 dual STAR-T Cell Injection/BCMA LILRB4 Dual STAR-T Cell Injection)) is a new STAR-T cell transfected by lentivirus.The study required that lymphocytes were collected from the subjects and cultured for 2-3 weeks to obtain YTS104 cell injection. Subjects were treated with fludarabine and cyclophosphamide chemotherapy prior to reinfusion, followed by a 2-day rest period before cell infusion.

Timeline

• Start date: 2023-06-28
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2023-06-22
• Last updated: 2025-08-15

Locations

1 site across 1 country: China