---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-21-361060"
form_type: "8-K"
ticker: "LYEL"
cik: "0001806952"
company_name: "Lyell Immunopharma, Inc."
filed_at: "2021-12-17T23:59:59+00:00"
generated_at: "2026-06-28T00:12:38.350028+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Lyell gets FDA IND clearance for LYL797 CAR-T; cGMP facility qualified; amends GSK deal

## Summary
- FDA cleared IND for LYL797, a ROR1-targeted CAR-T incorporating Gen-R and Epi-R; Phase 1 trial to screen TNBC patients by Q1 2022, initial data in 2023.
- Lyell's LyFE manufacturing center in Bothell, WA achieved cGMP qualification to support upcoming clinical trials for CAR, TIL, and TCR programs.
- Amended GSK agreement: Lyell will manufacture NY-ESO-1+Epi-R TCR product for Phase 1 trial; GSK to conduct trial under FTIH protocol.
- Lyell retains ownership of improvements to Epi-R and Gen-R technologies under amendment; eligible for milestones and royalties.

## SEC filing metadata
- accession: 0001193125-21-361060
- form_type: 8-K
- ticker: LYEL
- cik: 0001806952
- company_name: Lyell Immunopharma, Inc.
- filed_at: 2021-12-17T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 1.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1806952/000119312521361060/0001193125-21-361060-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1806952/000119312521361060/d262325d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-21-361060
- JSON: https://secwatch.observer/filing/0001193125-21-361060.json
- Plain text: https://secwatch.observer/filing/0001193125-21-361060.txt

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