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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04146051 | Descartes-08 CAR-T Cells in Generalized Myasthenia Gravis (MG) | PHASE2 | ACTIVE NOT_RECRUITING | 30 | — | — | Dec 4, 2019 | Mar 31, 2026 | May 28, 2025 | 15 | United States, Canada |
In Part 3, the primary objective is to compare the effect of Descartes-08 versus placebo, as measured by the change in MGC score from baseline to Week 12. In Part 1, up to three ascending doses of Descartes-08 will be administered to each of 3 to 6 patients; the patients will be staggered at least 21 days apart and will complete a safety review between each dose. In Part 2, patients will receive up to 6 doses in three different schedules depending on the arm they were enrolled into and will be monitored for up to 1 year to assess the safety and tolerability of a repeated dosing schedule.
| Arm | Type | Description |
|---|---|---|
| Phase 1b Dose-Escalation | EXPERIMENTAL | Generalized Myasthenia Gravis |
| Phase IIa Expansion | EXPERIMENTAL | Generalized Myasthenia Gravis |
| Phase IIb Randomized Control Trial | PLACEBO_COMPARATOR | Generalized Myasthenia Gravis |
| Name | Type | Description |
|---|---|---|
| Descartes-08 | DRUG | Autogolous T-cells expressing a chimeric antigen receptor directed to BCMA |
Inclusion Criteria: * Patient must be at least 18 years of age. * Patient must have Generalized Myasthenia Gravis at the time of screening. * Concomitant immunosuppressive drugs must be deemed necessary by the investigator. * Seronegative Patients are included Exclusion Criteria: * Major chronic ...