secwatch.observer — SEC 8-K summary
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Issuer:     FATE THERAPEUTICS INC (FATE)
CIK:        0001434316
Form:       8-K
Filed at:   2024-05-09T23:59:59+00:00
Accession:  0001193125-24-134840
Event type: other_material
Sentiment:  neutral
Materiality: 0.60
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Fate Therapeutics treats first SLE patient with FT819; advances autoimmune pipeline
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- First SLE patient dosed in Phase 1 autoimmunity study of FT819 (CD19 CAR T); discharged after 3 days with no notable AEs.
- FT819 translational data: rapid deep B-cell depletion, tissue trafficking, plasma cell depletion; fludarabine not required in some cases.
- FT522 (CAR NK) initial observations: rapid sustained B-cell depletion and enhanced persistence vs FT596 in first two BCL patients.
- Company completed dose escalation in FT819 BCM study; will focus FT819 solely on autoimmunity; FT522 IND for autoimmune diseases expected mid-2024.
- FT819 safety in BCM study: no DLTs, ICANS, or GvHD; low-grade CRS in 14% of patients; no study discontinuations or deaths.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1434316/000119312524134840/0001193125-24-134840-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1434316/000119312524134840/d675282d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-134840

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