secwatch.observer — SEC 8-K summary
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Issuer:     Century Therapeutics, Inc. (IPSC)
CIK:        0001850119
Form:       8-K
Filed at:   2023-12-06T23:59:59+00:00
Accession:  0001104659-23-123816
Event type: regulatory
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1850119/000110465923123816/0001104659-23-123816-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1850119/000110465923123816/tm2332239d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-23-123816

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer