Universal STAR-T Cell Injection in Generalized Myasthenia Gravis

Sponsor
Daishi Tian
Study ID
NCT07714798
Phase
PHASE1
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Generalized Myasthenia Gravis

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Universal STAR-T Cell — DRUG
    Subjects will receive infusion of Universal STAR-T Cells at the starting dose of 1.5E6 STAR+T cells/kg.

Study Details

This is a Phase I, single-arm, open-label, dose-escalation and dose-expansion study. This is an exploratory clinical study of universal STAR-T cell injection in patients with refractory generalized myasthenia gravis (GMG). Approximately 10-24 participants aged 18-65 years (inclusive) with the condition are planned to be enrolled. The primary objective is to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetic/pharmacodynamic (PK/PD) profile, and immunogenicity of universal STAR-T cell injection. The starting dose is 1.5E6 STAR+ T cells/kg, administered as a single intravenous infusion.Based on safety, PK results, and preliminary efficacy data obtained from the initial dose cohorts, a recommended dose will be selected for subsequent dose-expansion studies to further systematically evaluate the safety and efficacy of universal STAR-T cell injection. 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). The study is being conducted at Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology.

Key Dates

First listed
Jul 20, 2026
Start date
Jul 6, 2026
Status verified
Jul 2026
Primary completion
Jul 6, 2027
Completion
Jul 6, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Universal STAR-T Cell
    Subjects will receive infusion of Universal STAR-T Cells at the starting dose of 1.5E6 STAR+T cells/kg.

Primary Outcome Measure

Type, severity, and frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs). [ Time Frame: AEs observation will be follow-up for 24 weeks. The observation period is extended to 104 weeks. ]

Central Contacts

Related Studies