Drugs / Descartes-08
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03448978 | Mar 2018 → Apr 2021 | plasma cell myeloma | Cartesian Therapeutics | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07089121 | Jan 2026 → Dec 2027 expected | anti-neutrophil cytoplasmic antibody-associated vasculitis, juvenile dermatomyositis, juvenile myasthenia gravis, pediatric systemic lupus erythematosus | Cartesian Therapeutics | Recruiting | No outcome recorded |
| Phase 24 trials · 1 met primary | ||||||
| Phase 2 | NCT07391605 | Apr 2026 → Nov 2027 expected | antisynthetase syndrome | Cartesian Therapeutics | Recruiting | No outcome recorded |
| Phase 2 | NCT06038474 | Feb 2024 → Dec 2026 expected | systemic lupus erythematosus | Cartesian Therapeutics | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04816526 | Dec 2021 → Aug 2022 | plasma cell myeloma | Cartesian Therapeutics | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04146051 | Dec 2019 → Jul 2025 overdue | generalized myasthenia gravis | Cartesian Therapeutics | Active not recruiting | Met primary |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2025-11-13 | Cartesian Therapeutics | Results Cartesian Therapeutics Announces Strong Efficacy Signal in Phase 2 Trial of Descartes-08 in Patients with SLE and Expansion of Clinical Development into Myositis cartesiantherapeutics.com ↗
Consistent with clinical data reported to date from our myasthenia gravis program, Descartes-08 was well-tolerated in the outpatient setting and we saw a 100% LLDAS response rate in the three patients who reached Month 3. |
| 2025-04-08 | Cartesian Therapeutics | Results Cartesian Therapeutics’ Descartes-08 Observed to Provide Deep and Sustained Benefits Through Month 12 After a Single Course of Therapy in Phase 2b Myasthenia Gravis Trial cartesiantherapeutics.com ↗ |
| 2025-01-27 | Cartesian Therapeutics | Regulatory Cartesian Therapeutics Announces FDA Special Protocol Assessment Agreement for Phase 3 AURORA Trial of Descartes-08 in Myasthenia Gravis cartesiantherapeutics.com ↗
The SPA agreement indicates that the FDA has determined that the proposed trial design is acceptable to support a future Biologics License Application for Descartes-08 in MG, subject to the ultimate outcome of the trial. |
| 2024-12-03 | Cartesian Therapeutics | Results Cartesian Therapeutics Announces Positive Updated Results from Phase 2b Trial of Descartes-08 in Participants with Myasthenia Gravis and Outlines Design of Planned Phase 3 Trial cartesiantherapeutics.com ↗
Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced updated efficacy and safety data from the Phase 2b trial of Descartes-08 in participants with generalized myasthenia gravis (MG) and provided details on the design of its planned Phase 3 AURORA trial. |
| 2024-10-15 | Cartesian Therapeutics | Results Cartesian Therapeutics Announces Presentation of Results from Phase 2b Trial of Descartes-08 in Patients with Myasthenia Gravis at the 2024 MGFA Scientific Session of the AANEM Annual Meeting cartesiantherapeutics.com ↗ |
| 2024-09-09 | Cartesian Therapeutics | Regulatory Cartesian Therapeutics Receives FDA Rare Pediatric Disease Designation for Descartes-08 for the Treatment of Juvenile Dermatomyositis cartesiantherapeutics.com ↗
Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to Descartes-08 for the treatment of juvenile dermatomyositis (JDM). |
| 2024-07-02 | Cartesian Therapeutics | Results Cartesian Therapeutics Announces Positive Topline Results from Phase 2b Trial of Descartes-08 in Patients with Myasthenia Gravis cartesiantherapeutics.com ↗
Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (“Cartesian” or the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced positive topline results from its Phase 2b trial of Descartes-08 in patients with generalized myasthenia gravis (MG). |
| 2024-05-22 | Cartesian Therapeutics | Regulatory Cartesian Therapeutics Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for Descartes-08 for the Treatment of Myasthenia Gravis cartesiantherapeutics.com ↗
today announced that the U.S. Food and Drug Administration (“FDA”) has granted Regenerative Medicine Advanced Therapy (“RMAT”) designation for Descartes-08 for the treatment of myasthenia gravis (“MG”). |
| 2024-01-08 | Cartesian Therapeutics | Results Cartesian Therapeutics Highlights Progress and 2024 Strategic Priorities Across Innovative Pipeline of mRNA Cell Therapies for Autoimmunity cartesiantherapeutics.com ↗
Positive 12-month follow-up data from Phase 2a study in MG reported today; durable depletion of autoantibodies and clinically meaningful improvements in MG severity scores observed approximately 10 months after last infusion |
| 2024-01-08 | Cartesian Therapeutics | Results Cartesian Therapeutics Announces Positive Long-Term Follow-Up Data from Phase 2a Study of Lead mRNA Cell Therapy Candidate Descartes-08 in Patients with Myasthenia Gravis cartesiantherapeutics.com ↗
Cartesian Therapeutics, Inc. (NASDAQ: RNAC), (“the Company”) a clinical-stage biotechnology company pioneering mRNA cell therapies for autoimmune diseases, today announced positive twelve-month follow-up data from its Phase 2a trial of Descartes-08 in patients with generalized myasthenia gravis (MG), a chronic autoimmune disorder that causes disabling muscle weakness and fatigue. |
| 2023-06-22 | Cartesian Therapeutics | Results Cartesian Therapeutics Announces Landmark Study in The Lancet Neurology of First Successful Clinical Trial of RNA Cell Therapy in Autoimmunity cartesiantherapeutics.com ↗
The data demonstrate marked and long-lasting clinical improvement in patients with MG. |
| 2022-05-09 | Cartesian Therapeutics | Results Cartesian Therapeutics to Present Late-Breaking Data from Phase 1/2a Trial of RNA CAR T-cell Therapy in Patients with Generalized Myasthenia Gravis cartesiantherapeutics.com ↗
The treatment appears safe and well tolerated, and the extent of clinical improvement seen in our early participants is remarkable. |
| 2021-08-24 | Cartesian Therapeutics | Results Cartesian Therapeutics Announces Clinical Responses in First Cohort of Phase 1b/2a Trial in Myasthenia Gravis cartesiantherapeutics.com ↗
In cohort of three patients intended to test safety, all patients showed full-class improvement in the Myasthenia Gravis Foundation of America (MGFA) Clinical Classification and substantial improvement in Myasthenia Gravis Composite scale. |
All press releases naming this drug 16 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Descartes-08 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07391605 ↗ |
| Known as | Descarte-08 | “Safety, tolerability and efficacy of Descarte-08 in children, adolescents and young adults with childhood-onset systemic lupus erythematosus, ANCA-associated vasculitis,...” NCT07089121 ↗ |
| Modality | Cell therapy | “autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor” NCT03448978 ↗ |
| Route | Intravenous | “once-weekly intravenous infusions of Descartes-08” PMID 41514038 ↗ Jan 2026 |