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Decartes-08 · 1 trial · 1 indication
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...
Descartes-08 is an investigational mRNA CAR T-cell therapy being studied for the treatment of Myasthenia Gravis, a neurological autoimmune disorder. It is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
Descartes-08 targets BCMA, a protein found on plasma cells. By directing CAR T-cells against BCMA, the therapy aims to deplete the antibody-producing cells implicated in Myasthenia Gravis, potentially reducing the autoimmune attack on the neuromuscular junction.
Descartes-08 is being developed by Cartesian Therapeutics, Inc., a biopharmaceutical company publicly traded under the ticker symbol RNAC. The company is conducting clinical trials to evaluate the therapy's safety and efficacy in patients with Myasthenia Gravis.
Descartes-08 is currently in Phase 3 clinical development. It is an investigational therapy, meaning it has not been approved by the FDA or other regulatory bodies. The ongoing Phase 3 trial is designed to assess its potential as a treatment for Myasthenia Gravis.
Descartes-08 is being evaluated in a Phase 3 clinical trial registered as NCT06799247. This randomized, double-blind, placebo-controlled study is investigating the mRNA CAR T-cell therapy as a potential treatment for Myasthenia Gravis, with an enrollment of 128 participants across multiple countries.
Yes, Descartes-08 is an mRNA CAR T-cell therapy. It is designed to engineer a patient's T-cells to target BCMA, a protein on plasma cells. This approach is being studied in Myasthenia Gravis, a condition where plasma cells contribute to the production of pathogenic antibodies.