---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-123816"
form_type: "8-K"
ticker: "IPSC"
cik: "0001850119"
company_name: "Century Therapeutics, Inc."
filed_at: "2023-12-06T23:59:59+00:00"
generated_at: "2026-06-07T17:23:26.173663+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# FDA clears IND for Century's CNTY-101 in systemic lupus erythematosus

## Summary
- FDA notified Century that Phase 1 trial of CNTY-101 may proceed in moderate-to-severe SLE patients who failed ≥2 immunosuppressive therapies.
- This is the second IND clearance for CNTY-101 and first in autoimmune/inflammatory disease; previous IND for B-cell malignancies.
- Trial expected to start H1 2024 with initial data by year-end 2024; evaluates safety, tolerability, PK, clinical response.
- CNTY-101 is an allogeneic iPSC-derived NK cell with 6 genetic edits including CD19 CAR, Allo-Evasion, IL-15, and safety switch.

## SEC filing metadata
- accession: 0001104659-23-123816
- form_type: 8-K
- ticker: IPSC
- cik: 0001850119
- company_name: Century Therapeutics, Inc.
- filed_at: 2023-12-06T23:59:59+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/1850119/000110465923123816/0001104659-23-123816-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1850119/000110465923123816/tm2332239d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-123816
- JSON: https://secwatch.observer/filing/0001104659-23-123816.json
- Plain text: https://secwatch.observer/filing/0001104659-23-123816.txt

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