OncoMatch/Clinical Trials/NCT06594445
HM2023-05: GTB-3650 Trike for High Risk MDS and R/R AML
Official title: HM2023-05: GTB-3650 (Anti-CD16/IL-15/Anti-CD33) Tri-Specific Killer Engager (TriKE®) for the Treatment of High Risk Myelodysplastic Syndromes (MDS) and Refractory/Relapsed Acute Myeloid Leukemia (AML)
Is NCT06594445 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1 trial studies GTB-360 for myeloid malignancy.
Treatment: GTB-360 — 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 suppressor cells (MDSC) which contribute to a tumor induced immunosuppression. Because CD16 is the most potent activating receptor on NK cells, this single agent may induce a targeted antiCD33+ tumor response
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Myeloproliferative Neoplasm
Prior therapy
Cannot have received: hematopoietic stem cell transplant
Exception: not a candidate for HSCT or not newly relapsed after HSCT (no post-HSCT therapy given)
A candidate for hematopoietic stem cell transplant (HSCT) or newly relapsed after HSCT (e.g. no post-HSCT therapy given)
Cannot have received: anticancer therapy
Exception: therapy within 14 days of Cycle 1 Day 1
No anticancer therapy within 14 days of Cycle 1 Day 1; any AEs from therapy given prior must have resolved to Grade 1 or baseline
Cannot have received: intrathecal chemotherapy
Exception: within 14 days prior to Day 1
administration of IT chemotherapy within 14 days prior to Day 1
Lab requirements
Blood counts
Exact limits: see the full eligibility criteria on this page.
Kidney function
Adequate organ function within 14 days (30 days for cardiac) of Cycle 1 Day 1
Liver function
Adequate organ function within 14 days (30 days for cardiac) of Cycle 1 Day 1
Cardiac function
Exact limits: see the full eligibility criteria on this page.
Adequate organ function within 14 days (30 days for cardiac) of Cycle 1 Day 1; Peripheral blasts ≤ 20,000 at the time of treatment start; QTc interval > 480 msec at screening; a family history of long QT syndrome
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Masonic Cancer Center · Minneapolis, Minnesota
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06594445 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior hematopoietic stem cell transplant, anticancer therapy, intrathecal chemotherapy disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify