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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Dose Limiting Toxicity
Timeframe: Within 28 days after infusion
The incidence and frequency of treatment-emergent adverse events
Timeframe: Within 12 months after infusion
Best overall response rate (BOR) of each dose group
Timeframe: Within 12 weeks after infusion
Objective response rate (ORR) of each dose group
Timeframe: Within 4 weeks after infusion
Time to response (TTR)
Timeframe: Within 6 months after infusion