secwatch.observer — SEC 8-K summary
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Issuer:     Arcellx, Inc. (ACLX)
CIK:        0001786205
Form:       8-K
Filed at:   2024-12-09T23:59:59+00:00
Accession:  0001193125-24-272814
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Arcellx iMMagine-1 study: 97% ORR, 62% CR/sCR, no delayed neurotoxicity in RRMM
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- Phase 2 pivotal iMMagine-1: 86 patients evaluable; ORR 97% (83/86), CR/sCR 62% (53/86) at median 9.5-month follow-up.
- No delayed neurotoxicities (Parkinsonism, cranial nerve palsies, Guillain-Barré) in >150 dosed patients across Phase 1 and iMMagine-1.
- Phase 1 study shows 30.2-month median PFS at 38.1 months follow-up; median OS not reached.
- MRD negativity achieved in 93.1% (54/58) evaluable at ≥10⁻⁵ sensitivity.
- Safety: 86% had Grade ≤1 CRS; 91% had no ICANS; most common Grade ≥3 TEAE was neutropenia (54%).

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1786205/000119312524272814/0001193125-24-272814-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1786205/000119312524272814/d917635d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-272814

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