A Clinical Study to Evaluate the Safety and Efficacy of GT802 Injection in the Treatment of Refractory Generalized Myasthenia Gravis
NCT07917923, Early phase 1, Not yet recruiting, Daishi Tian
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Clinical Study to Evaluate the Safety and Efficacy of GT802 Injection in the Treatment of Refractory Generalized Myasthenia Gravis | ClinicalTrials.gov |
| NCT number | NCT07917923 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Early phase 1 | ClinicalTrials.gov |
| Enrollment | 12 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Daishi Tian | ClinicalTrials.gov |
| Conditions | Generalized Myasthenia Gravis (gMG) | ClinicalTrials.gov |
| Interventions | GT802 Injection | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Adverse Events (AEs) occurring after infusion and their proportions | From infusion to at least 1 year | Adverse Events (AEs) occurring after infusion and their proportions | ClinicalTrials.gov |
| Secondary | Quantitative Myasthenia Gravis (QMG) score | From infusion to 12 months | To assess the preliminary efficacy of GT802 Injection in participants with refractory generalized myasthenia gravis per QMG score. | ClinicalTrials.gov |
| Secondary | Myasthenia Gravis Activities of Daily Living (MG-ADL) score | From infusion to 12 months | To assess the preliminary efficacy of GT802 Injection in participants with refractory generalized myasthenia gravis per MG-ADL score. | ClinicalTrials.gov |
| Secondary | Time to maximum amplification (Tmax) | From infusion to 12 months | Time to maximum amplification (Tmax) of cells following GT802 infusion | ClinicalTrials.gov |
| Secondary | Maximum amplification (Cmax) | From infusion to 12 months | The maximum observed concentration of the circulating GT802 CAR-T cells | ClinicalTrials.gov |
| Secondary | Area under the curve (AUC) | From infusion to 12 months | Area under the curve (AUC) of cellular expansion following GT802 infusion | ClinicalTrials.gov |
| Secondary | Duration of Detectable Concentration (Tlast) | From infusion to 12 months | Duration of Detectable Concentration (Tlast) refers to the time period from the infusion of GT802 cells to the last time point at which the target cells can be detected in the peripheral blood or target tissues. | ClinicalTrials.gov |
| Secondary | Chimeric Antigen Receptor T cell (CAR-T)-associated serum cytokines | From infusion to 2 months | Monitor serum cytokine levels after infusion | ClinicalTrials.gov |
| Secondary | Anti-drug antibodies (ADA) Response to GT802 Measured by Immunoassay. | From infusion to 12 months | Changes in anti-drug antibodies (ADA) before and after treatment. Serum anti-drug antibody (ADA) response to GT802, including anti-CAR and anti-PEG antibodies, measured by immunoassay. Samples collected at pre-screening (PEG only), Day 14, Day 28, Month 3, Month 6, and Month 12 post-first infusion. Positive results trigger titer confirmation and continued monitoring until negative or below lower limit of detection. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)