Universal STAR-T Cell(BriSTAR Immunotech)

This is a Phase I, single-arm, open-label, dose-escalation and dose-expansion study.
This study evaluates the safety and efficacy of universal STAR-T cells in patients with R/R CTD-associated Immune Thrombocytopenia (CTD-ITP). Approximately 9 patients aged 18-65 will receive infusion of universal STAR-T cells at the starting dose of 3E6 STAR+T cells/kg. The main purpose of exploratory clinical research is to explore the efficacy and safety of universal STAR-T cell and the lymphodepletion regimen. The primary endpoint is observations of types, severity, and frequency of adverse events (AEs) and efficacy assessment. This single-arm, open-label trial will enroll patients across Chinese People's Liberation Army (PLA) General Hospital.

This is a Phase I, single-arm, open-label, dose-escalation and dose-expansion study.
The main objective is to explore the safety and tolerability of the universal STAR-T cell injection in patients with progressive or relapsing-remitting multiple sclerosis (MS).The secondary objectives are to evaluate the efficacy of the universal STAR-T cell injection in treating patients with progressive or relapsing-remitting MS; and to assess the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of the universal STAR-T cell injection.
The primary endpoint of this study is the incidence rate of dose-limiting toxicity (DLT), as well as the types, severity and frequency of adverse events (AE).The secondary research endpoints of this study are the efficacy endpoints as well as the expansion and persistence of the universal STAR-T cells in the body.
This study is an exploratory clinical trial of the universal STAR-T cell injection for the treatment of progressive or relapsed-remitting MS. The study will be conducted in two phases: dose escalation and dose expansion. The dose escalation group 1 (1.5E6 STAR-T cells) begins, followed by dose escalation group 2 (3E6 STAR-T cells), and dose escalation group 3 (4.5E6 STAR-T cells).
Expansion study phase: After the dose escalation stage is completed, based on the safety, PK results and preliminary efficacy data of each dose group during the escalation stage, the recommended dose will be determined for the dose expansion study. It is planned to include 3 to 6 subjects to further systematically evaluate the safety and efficacy of the universal STAR-T cell.
This study includes the screening period (from D-28 to D-6), the pre-clearance treatment and rest observation period (from D-5 to D-1), the cell infusion and main study endpoint observation period (from D0 to W12 after infusion), and the follow-up period (from W12 after infusion to W104).