Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Descartes-08 · 4 trials · 7 indications
Proportion of participants in the Descartes-08 group compared with placebo who achieve major improvement marked by ≥60 point improvement on the 2016 ACR/EULAR Total Improvement Score (TIS)
Results will be descriptive. Safety and tolerability endpoints will include descriptive statistics of AEs and SAEs. Patients must be followed until all AEs have resolved to Grade 2 or less except for lymphopenia and alopecia.
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.
The primary endpoint for Part-1 is the Maximum Tolerated Dose (MTD), defined as the Dose Level at which no more than 20% of the patients treated have shown Dose-Limiting Toxicity (DLT), i.e. at which 3 patients received all 6 weekly infusions without a DLT by Day 50; or 6 patients received 3 weekly infusions with no more than 1 patient having a DLT by Day 50. The primary endpoint for Part-2 is the type and frequency of treatment-related SAEs. This will be assessed on Days 22, 50 and Months 3,6,9,12
The primary endpoint for Part-1 is the Maximum Tolerated Dose (MTD), defined as the Dose Level at which no more than 20% of the patients treated have shown Dose-Limiting Toxicity (DLT), i.e. at which 3 patients received all 6 weekly infusions without a DLT by Day 50; or 6 patients received 3 weekly infusions with no more than 1 patient having a DLT by Day 50. The primary endpoint for Part-2 is the type and frequency of treatment-related SAEs.
| Arm | Type | Description |
|---|---|---|
| Decartes-08 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Descartes-08 | OTHER | Drug: Descartes-08 Autologous T-cells expressing a chimeric antigen receptor directed to BCMA |
| 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 |
| Part 1: Decartes-08 to establish Maximum tolerated dose | EXPERIMENTAL | Intra-patient dose escalation arm with three dose levels over the course of six infusions of cell product. |
| Part 2: Decartes-08 infusions once weekly for 6 weeks | EXPERIMENTAL | Descartes-08 infusions at the maximum tolerated dose level from Part 1. |
| Name | Type | Description |
|---|---|---|
| Descartes-08 | DRUG | Autologous T-cells expressing a chimeric antigen receptor (CAR) directed to B-Cell maturation antigen (BCMA) |
| Placebo | OTHER | Plasma-Lyte |
Inclusion Criteria: * Confirmed diagnosis of one of the following: Dermatomyositis (DM): Probability score ≥55% on the 2017 EULAR/ACR (European Alliance of Associations of Rheumatology/ American College of Rheumatology) criteria for classification of dermatomyositis (corresponding to diagnosis of ...
Descartes-11, also known as Descartes-08, is an investigational monoclonal antibody being developed for multiple autoimmune and oncologic conditions. Its target indications include Systemic Lupus Erythematosus (SLE), Childhood-onset Systemic Lupus Erythematous, Antisynthetase Syndrome, Generalized Myasthenia Gravis, and Multiple Myeloma. It is currently in Phase 2 clinical development.
Descartes-11 is being developed by Cartesian Therapeutics, Inc., a biopharmaceutical company traded under the ticker symbol RNAC. The company is conducting clinical trials for this investigational therapy across several autoimmune indications, including systemic lupus erythematosus and generalized myasthenia gravis.
Descartes-11 is currently in Phase 2 clinical development. It has received FDA designations including Rare Pediatric Disease, Regenerative Medicine Advanced Therapy (RMAT), and Orphan Drug designation. The drug remains investigational and has not been approved by regulatory authorities.
Descartes-11 is being studied in several clinical trials. NCT04146051 is a Phase 2 trial in generalized myasthenia gravis with 30 participants. NCT06038474 is a Phase 2 trial in systemic lupus erythematosus with 6 participants. NCT07089121 is a Phase 1 trial in children and young adults with autoimmune disorders. NCT07391605 is a Phase 2 trial in antisynthetase syndrome.
Yes, Descartes-11 is also known as Descartes-08. The drug is referred to by both names in clinical development. Cartesian Therapeutics is evaluating this therapy across multiple autoimmune conditions, including myasthenia gravis, systemic lupus erythematosus, and antisynthetase syndrome.
Descartes-11 is a monoclonal antibody-based therapy. As a monoclonal antibody, it is designed to target specific proteins or cells involved in disease processes. The drug is being investigated for its potential to modulate immune responses in autoimmune diseases and for its anti-cancer properties in multiple myeloma.