HM2023-05: GTB-3650 Trike for High Risk MDS and R/R AML

This is a Phase I dose finding study of GTB-3650 (anti-CD16/IL-15/anti-CD33) Tri-Specific Killer Engager (TriKE®) for the treatment of select CD33-expressing refractory/relapsed myeloid malignancies in adults ≥ 18 years of age who are not a candidate for potentially curative therapy, including hematopoietic stem cell transplantation, and are refractory to, intolerant of, or ineligible for therapy options that are known to provide clinical benefit. The hypothesis is GTB-3650 TriKE will induce natural killer (NK) cell function by targeting malignant cells, as well as, CD33+ myeloid derived suppr

Trial Details

NCT ID
NCT06594445
Phase
PHASE1
Sponsor
Masonic Cancer Center, University of Minnesota
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • GTB-360
Locations (sample)
  • Minneapolis, Minnesota, United States|44.97997,-93.26384

Key Eligibility Criteria

  • Diagnosis of a high risk myelodysplastic syndromes (MDS), treatment related MDS, OR relapsed/refractory acute myelogenous leukemia (AML).
  • Absolute lymphocyte count (ALC) ≥ 200 cells/µL OR absolute circulating CD56+/CD3- NK cell count \>25 cells/µL within the 14 days prior to Cycle 1 D…
  • Peripheral blasts ≤20,000 at the time of treatment start. Hydroxyurea may be used up to Day 1 of the 1st cycle to achieve this threshold and contin…
  • Karnofsky performance status ≥ 70%

For full eligibility, visit ClinicalTrials.gov.

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