{"entity":{"id":"gtb-3650","kind":"drug","name":"GTB-3650","aka":["GTB-3650 TriKE"],"tldr":"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.","status":"phase-1","asOf":"2026-11-04","links":[{"label":"GT Biopharma: product pipeline","url":"https://www.gtbiopharma.com/product-pipeline/overview"},{"label":"ClinicalTrials.gov: NCT06594445","url":"https://clinicaltrials.gov/study/NCT06594445"}],"tags":["pipeline"],"related":[],"cancers":[],"sections":[],"technologies":["nk-cell-engagers"],"targets":["cd33"],"drugs":[],"companies":["gt-biopharma"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo startup monitors","editedOn":"2026-11-04"},"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.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/gtb-3650/","neighbours":{"technology":[{"id":"nk-cell-engagers","kind":"technology","name":"NK cell engagers","route":"/technologies/nk-cell-engagers/"}],"target":[{"id":"cd33","kind":"target","name":"CD33","route":"/targets/cd33/"}],"company":[{"id":"gt-biopharma","kind":"company","name":"GT Biopharma","route":"/companies/gt-biopharma/"}]}}