secwatch.observer — SEC 8-K summary
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Issuer:     Senti Biosciences, Inc. (SNTI)
CIK:        0001854270
Form:       8-K
Filed at:   2023-12-22T23:59:59+00:00
Accession:  0001854270-23-000134
Event type: regulatory
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Senti Bio receives FDA IND clearance for SENTI-202 CAR-NK therapy for AML
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- FDA cleared IND for SENTI-202, an off-the-shelf CAR-NK cell therapy targeting CD33/FLT3 hematologic malignancies including AML.
- Phase 1 trial expected to treat first patient in Q2 2024 at multiple US and Australia sites.
- Initial efficacy data expected by year-end 2024; durability data expected in 2025.
- Trial evaluates two dose levels (1 or 1.5 billion cells) with three weekly doses after lymphodepletion and optional continuation cycles.
- Manufacturing expenses for Phase 1 largely prepaid through existing GeneFab agreement.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1854270/000185427023000134/0001854270-23-000134-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1854270/000185427023000134/snti-20231222.htm
  HTML page:      https://secwatch.observer/filing/0001854270-23-000134

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