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NOT YET RECRUITING
NCT06770504
PHASE1

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

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

7

Start Date

2025-01-16

Completion Date

2026-12-30

Last Updated

2025-01-13

Healthy Volunteers

No

Interventions

BIOLOGICAL

YTS109

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