NCT07523100

A Study on the Safety and Tolerability of Universal STAR-T Cell Therapy for Multiple Sclerosis.

A Clinical Study on the Safety and Tolerability of Universal STAR-T Cell Injection in Patients With Multiple Sclerosis.

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Daishi Tian · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Multiple Sclerosis (MS)

Interventions

Type	Name	Description
DRUG	Universal STAR-T Cell Injection	Subjects will receive Universal STAR-T Cell Injection, and dose escalation will commence at 1.5E6 cells/kg or the starting dose may be adjusted based on accumulated data.

Timeline

• Start date: 2026-04-07
• Primary completion: 2027-04-01
• Completion: 2029-04-01
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: China