# GTB-3650

Source: https://onco.cc/drugs/gtb-3650/  
OnCo record `gtb-3650` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

GTB-3650 is a protein from GT Biopharma that wakes up natural killer cells and points them at leukaemia cells carrying the CD33 marker. It is in a first trial in people whose leukaemia has come back.

## Summary

GTB-3650 is GT Biopharma's first second-generation camelid nanobody TriKE. The IND was cleared and enrolment began on 21 January 2025 in a phase 1 dose-escalation study (NCT06594445) in relapsed or refractory CD33-expressing haematological cancers, including refractory acute myeloid leukaemia and high-risk myelodysplastic syndrome, with up to seven cohorts of two patients and dosing in two-week blocks for up to four months.

## Fields

- Kind: Treatment
- Status: phase-1
- Last checked: 2026-11-04
- Also known as: GTB-3650 TriKE
- Tags: pipeline
- Code: GTB-3650
- Modality: Tri-specific natural killer cell engager (camelid nanobody)
- Mechanism: A single fusion protein of a camelid nanobody against CD16 on natural killer cells, a single-chain variable fragment against CD33 on tumour cells, and wild-type human IL-15 to drive natural killer cell expansion, as described by GT Biopharma.

## Sources

- GT Biopharma: product pipeline: https://www.gtbiopharma.com/product-pipeline/overview
- ClinicalTrials.gov: NCT06594445: https://clinicaltrials.gov/study/NCT06594445

## Connected records

- technologies: [NK cell engagers](https://onco.cc/technologies/nk-cell-engagers/)
- targets: [CD33](https://onco.cc/targets/cd33/)
- companies: [GT Biopharma](https://onco.cc/companies/gt-biopharma/)

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JSON: https://onco.cc/api/v1/entities/gtb-3650.json