---
schema_version: "secwatch.filing_event.v1"
accession: "0001737287-23-000096"
form_type: "8-K"
ticker: "ALLO"
cik: "0001737287"
company_name: "Allogene Therapeutics, Inc."
filed_at: "2023-12-19T23:59:59+00:00"
generated_at: "2026-06-07T10:37:45.611442+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Allogene gets FDA Fast Track for ALLO-647; safety data from 87 patients at ASH

## Summary
- FDA granted Fast Track Designation for ALLO-647 in adult patients with r/r LBCL.
- Safety review of 87 Phase 1 patients: no unexpected safety concerns, no GvHD or Grade ≥3 ICANS.
- 33 CAR T-naïve LBCL patients had 42% CR rate, median DOR 23.1 months.
- EXPAND trial (N=70 r/r LBCL) enrolling in US/EU to support licensure of ALLO-647.
- Grade ≥3 cytopenias decreased over time; rates consistent with autologous CAR T therapy.

## SEC filing metadata
- accession: 0001737287-23-000096
- form_type: 8-K
- ticker: ALLO
- cik: 0001737287
- company_name: Allogene Therapeutics, Inc.
- filed_at: 2023-12-19T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1737287/000173728723000096/0001737287-23-000096-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1737287/000173728723000096/allo-20231209.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001737287-23-000096
- JSON: https://secwatch.observer/filing/0001737287-23-000096.json
- Plain text: https://secwatch.observer/filing/0001737287-23-000096.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.