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RecruitingPhase 1NCT06594445

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

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)

Sponsor

Masonic Cancer Center, University of Minnesota

Enrollment

45 participants

Start Date

Nov 19, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid LeukemiaMyelodysplastic SyndromesMyeloid Malignancy

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called GTB-3650 (a TriKE — a molecule designed to activate your natural killer immune cells against cancer) for people with high-risk myelodysplastic syndrome (MDS) or relapsed/refractory acute myeloid leukemia (AML). **You may be eligible if...** - You have been diagnosed with high-risk MDS, treatment-related MDS, or relapsed/refractory AML - You have enough immune cells in your blood to work with this therapy - Your blast count (immature blood cells) can be kept below 20,000 - Your general health is good enough (Karnofsky score 70% or above) - Your organ function is adequate - You are willing to use contraception and stay near the study center during the first treatment cycle **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have active or uncontrolled infection - You have had certain recent transplants or other serious conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGTB-360

GTB-3650 is administered by a continuous infusion (CI). A patient's dose of GTB-3650 is calculated using their assigned Dose Level and their actual body weight (ABW) obtained within 5 days prior to or on Cycle 1, Day 1. Dose Level 1: 1.25 ug/kg/day Dose Level 2: 2.5 ug/kg/day Dose Level 3: 5 ug/kg/day Dose Level 4: 10 ug/kg/day Dose Level 5: 25 ug/kg/day Dose Level 6: 50 ug/kg/day Dose Level 7: 100 ug/kg/day

Locations(1)

Masonic Cancer Center

Minneapolis, Minnesota, United States

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