Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06799247 | Investigating an mRNA CAR T-cell Therapy, Known as Descartes-08, as a Potential Approach to Treat Myasthenia Gravis | PHASE3 | RECRUITING | 100 | — | — | May 6, 2025 | Sep 30, 2027 | Mar 24, 2026 | 34 | United States, Canada +6 |
To evaluate the efficacy of Descartes-08 as assessed by the proportion of Myasthenia Gravis Activities of Daily Living (MG-ADL) responders at Month 4.
| Arm | Type | Description |
|---|---|---|
| Decartes-08 | EXPERIMENTAL | This group will undergo leukapheresis and receive manufactured Decartes-08 |
| Placebo | PLACEBO_COMPARATOR | This group will receive placebo |
| Name | Type | Description |
|---|---|---|
| Decartes-08 | BIOLOGICAL | Autologous mRNA CAR T-cell therapy |
| Placebo Drug | OTHER | infusion without Decartes-08 |
Inclusion Criteria: * Patient must be at least 18 years of age. * Patient must have generalized myasthenia gravis (gMG), Myasthenia Gravis Foundation of America (MGFA) clinical classification grades 2-4 at the time of Sscreening. * MG-Activities of Daily Living (MG ADL) total score ≥ 6. * Concomita...