U.S., March 7 -- ClinicalTrials.gov registry received information related to the study (NCT07453836) titled 'Research on YTS109 Cell in Patients With Recurrent/Refractory Autoimmune Hemolytic Anemia' on March 02.
Brief 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 STAR-T cell therapy in patients with autoimmune hemolytic anemia who have failed >=3 lines of therapy.
This study set up two dosage groups: 1e6 STAR+T cells/kg and 2e6 STAR+T cells/kg. With the starting dose of 1e6 STAR+T cells/kg, it was conducted according to the traditional 3+3 design rule. In this study, if ...