---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-23-043582"
form_type: "8-K"
ticker: "GTBP"
cik: "0000109657"
company_name: "GT Biopharma, Inc."
filed_at: "2023-12-04T23:59:59+00:00"
generated_at: "2026-06-07T18:33:12.674325+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# GT Biopharma submits IND to FDA for GTB-3650 for CD33+ leukemia

## Summary
- IND submitted for GTB-3650, a 2nd generation nanobody TriKE targeting CD33+ leukemia (relapsed/refractory AML and high-risk MDS).
- Interim CEO Michael Breen says company aims to move GTB-3650 into the clinic expeditiously in 2024.
- GTB-3650 is based on the proprietary TriKE NK cell engager platform licensed from University of Minnesota.

## SEC filing metadata
- accession: 0001493152-23-043582
- form_type: 8-K
- ticker: GTBP
- cik: 0000109657
- company_name: GT Biopharma, Inc.
- filed_at: 2023-12-04T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/109657/000149315223043582/0001493152-23-043582-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/109657/000149315223043582/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-23-043582
- JSON: https://secwatch.observer/filing/0001493152-23-043582.json
- Plain text: https://secwatch.observer/filing/0001493152-23-043582.txt

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