secwatch.observer — SEC 8-K summary
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Issuer:     FATE THERAPEUTICS INC (FATE)
CIK:        0001434316
Form:       8-K
Filed at:   2021-12-14T23:59:59+00:00
Accession:  0001193125-21-356947
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Fate Therapeutics reports positive FT516 and FT596 Phase 1 data; FT516 gets RMAT designation for DLBCL
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- FT516: 6 of 10 CAR T-naive patients in ongoing response at median 9.1 months; 3 of 8 prior CAR T patients achieve CR.
- FDA granted RMAT designation for FT516 in relapsed/refractory DLBCL; dose expansion at 900M cells/dose initiated.
- FT596: 5 of 6 patients achieve objective response (4 CR) with single dose at 900M cells in combination with rituximab.
- FT596: 10 of 11 patients treated with second cycle continue in ongoing response; 3 in CR ≥6 months. No ICANS or GvHD observed.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1434316/000119312521356947/0001193125-21-356947-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1434316/000119312521356947/d267979d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-21-356947

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