NCT06770504

A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia

The Safety and Efficacy of YTS109 Cell Injection for Relapsed/Refractory Autoimmune Hemolytic Anemia Patients After Receiving Three or More Lines of Therapy.

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I, single-arm, open-label, dose-escalation and dose-expansion study. The primary objective is to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of YTS109 START T-cell therapy in patients with autoimmune hemolytic anemia who have failed ≥3 lines of therapy.

Conditions

• Autoimmune Hemolytic Anemia
• Anti-CD19 STAR T-cell Therapy
• Failure ≥3 Lines of Therapies

Interventions

Type	Name	Description
BIOLOGICAL	YTS109	In this study, subjects will receive YTS109 Cell Injection(0.5-1E6 STAR+T cell/kg) once.

Timeline

• Start date: 2025-01-16
• Primary completion: 2025-12-30
• Completion: 2026-12-30
• First posted: 2025-01-13
• Last updated: 2025-01-13