---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-24-038718"
form_type: "8-K"
ticker: "CLDI"
cik: "0001855485"
company_name: "Calidi Biotherapeutics, Inc."
filed_at: "2024-09-30T23:59:59+00:00"
generated_at: "2026-05-31T00:53:58.689979+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# FDA clears IND for Calidi's CLD-101 Phase 1b/2 trial in high-grade glioma

## Summary
- FDA cleared Northwestern University's IND for CLD-101, a stem cell-based oncolytic virus therapy for high-grade glioma.
- Phase 1b/2 trial will evaluate safety/feasibility of multiple doses in newly diagnosed patients; expected to start Q1 2025.
- Prior Phase 1 trial showed median overall survival 18.4 months and no dose-limiting toxicity (Lancet Oncology 2021).
- Additional Phase 1 trial in recurrent high-grade glioma at City of Hope with interim data expected H1 2025.

## SEC filing metadata
- accession: 0001493152-24-038718
- form_type: 8-K
- ticker: CLDI
- cik: 0001855485
- company_name: Calidi Biotherapeutics, Inc.
- filed_at: 2024-09-30T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1855485/000149315224038718/0001493152-24-038718-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1855485/000149315224038718/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-24-038718
- JSON: https://secwatch.observer/filing/0001493152-24-038718.json
- Plain text: https://secwatch.observer/filing/0001493152-24-038718.txt

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