NCT07714798 Universal STAR-T Cell(BriSTAR Immunotech) Myasthenia Gravis Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07714798 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 7 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07714798 is a hot trial to watch
Myasthenia Gravis is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07714798 is notable because it evaluates Universal STAR-T Cell(BriSTAR Immunotech) in a Phase 1 design sponsored by Huazhong University of Science Tongji Hospital, Tongji Medical College. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07714798 |
| Official title | Universal STAR-T Cell Injection in Generalized Myasthenia Gravis |
| Phase / status | Phase 1 / Not yet recruiting |
| Intervention | Universal STAR-T Cell(BriSTAR Immunotech) |
| Sponsor | Huazhong University of Science Tongji Hospital, Tongji Medical College |
| Geography | China |
| Enrollment | [object Object] |
| Primary endpoint | Type, severity, and frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs). |
| Endpoint time frame | AEs observation will be follow-up for 24 weeks. The observation period is extended to 104 weeks. |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
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-c
Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment of [object Object] participants across China shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Type, severity, and frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs). (AEs observation will be follow-up for 24 weeks. The observation period is extended to 104 weeks.) — Characterization of treatment-emergent adverse events (TEAEs) graded by NCI-CTCAE v6.0, including laboratory abnormalities, vital sign changes, and infusion-related reactions.
- Incidence of Dose-Limiting Toxicities (DLTs). (Within 28 days after infusion) — To assess the safety and tolerability of \[Drug Name\] and determine the Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D). DLTs are defined according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
Readout outlook and evidence gap
The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
Build a living trial monitor: connect to PatSnap MCP Servers and track recruitment, endpoint revisions, projected readouts and new result records without manually reconciling separate databases.
Asset and sponsor context
Drug & Asset MCP profile: Universal STAR-T Cell(BriSTAR Immunotech) is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.
Company & Deal Intelligence MCP profile: Huazhong University of Science Tongji Hospital, Tongji Medical College is resolved to a normalized organization record in Wuhan, China. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07714798 provides a focused lens on Myasthenia Gravis development. Its value will be determined by whether Universal STAR-T Cell(BriSTAR Immunotech) can convert the current Phase 1 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
Ready to reproduce this analysis? Explore PatSnap MCP Servers and combine Clinical Trials, Drug & Asset, and Company & Deal Intelligence as reusable building blocks for trial monitoring and SEO-ready clinical reports.
