---
schema_version: "secwatch.filing_event.v1"
accession: "0001453687-25-000050"
form_type: "8-K"
ticker: "RNAC"
cik: "0001453687"
company_name: "Cartesian Therapeutics, Inc."
filed_at: "2025-01-27T23:59:59+00:00"
generated_at: "2026-05-27T09:11:07.802647+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Cartesian Therapeutics receives FDA SPA agreement for Phase 3 AURORA trial of Descartes-08 in MG

## Summary
- FDA agrees under Special Protocol Assessment that Phase 3 AURORA trial design can support future BLA for Descartes-08 in myasthenia gravis.
- Phase 3 trial expected to start in first half of 2025; randomized, placebo-controlled, 100 AChR Ab+ participants.
- Primary endpoint: proportion with ≥3-point MG-ADL improvement at Month 4 vs placebo; 1:1 randomization.
- Phase 2b data showed average MG-ADL reduction of 5.5 (±1.1) at Month 4 (n=12); well-tolerated without preconditioning chemo.
- SPA provides regulatory clarity and a clear path toward potential approval of Descartes-08.

## SEC filing metadata
- accession: 0001453687-25-000050
- form_type: 8-K
- ticker: RNAC
- cik: 0001453687
- company_name: Cartesian Therapeutics, Inc.
- filed_at: 2025-01-27T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1453687/000145368725000050/0001453687-25-000050-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1453687/000145368725000050/rnac-20250127.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001453687-25-000050
- JSON: https://secwatch.observer/filing/0001453687-25-000050.json
- Plain text: https://secwatch.observer/filing/0001453687-25-000050.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.