GTB-3650 Tri-Specific Killer Engager (TriKE®)

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)

What's the purpose of the trial?

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
Trial status

Accepting patients

Phase
Phase 1
Enrollment
45
Last Updated
2 weeks ago
Am I Eligible

Participating Centers

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Experimental Treatments

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  • GTB-360

Arms / Cohorts

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Accepting patients

Dose Level 1: 1.25 ug/kg/day

Accepting patients

Dose Level 2: 2.5 ug/kg/day

Accepting patients

Dose Level 3: 5 ug/kg/day

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