GTB-3550 Tri-Specific Killer Engager (TriKE®) for High Risk Hematological Malignancies

Stopped early · Phase 1/Phase 2

Conditions studied: High-risk Myelodysplastic Syndromes, Acute Myelogenous Leukemia, Systemic Mastocytosis, Mast Cell Leukemia

In brief

This is a multi-center Phase I/II clinical trial of GTB-3550 (CD16/IL-15/CD33) tri-specific killer cell engager (TriKE®) for the treatment of CD33-expressing high risk myelodysplastic syndromes, refractory/relapsed acute myeloid leukemia or advanced systemic mastocytosis. The hypothesis is that GTB-3550 TriKE® will induce natural killer cell function by targeting malignant cells as well as CD33+ myeloid derived suppressor cells (MDSC) which contribute to tumor induced immunosuppression. Because CD16 is the most potent activating receptor on natural killer (NK) cells, this single agent may induce a targeted anti-CD33+ tumor response.

Key facts

Study ID

NCT03214666

Run by

GT Biopharma, Inc.

People needed

12

Starts

2020-01-01

Expected to finish

2021-09-29

Last updated by the study team

2022-11-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• New or progressive pulmonary infiltrates on screening chest x-ray or chest computerized tomography (CT) scan unless cleared for study by Pulmonary. Infiltrates attributed to infection must be stable/improving with associated clinical improvement after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections).
• Uncontrolled bacterial, fungal or viral infections, known history of HIV
• Active Hepatitis B or Hepatitis C (virus detectable by polymerase chain reaction [PCR]) - chronic asymptomatic viral hepatitis is allowed
• Other concurrent active cancer within the last year (excluding non-melanoma skin cancers)
• Severely clinically obese patients, BMI >38
• Currently taking any over-the-counter (OTC), vitamin, mineral, or dietary supplement within 14 days prior to study drug administration on Day 1 and during study conduct that may confound study safety goals (e.g., St. John's wort). Questions should be discussed with GT Biopharma.
• Pregnant or breast feeding. The effect of GTB-3550 TriKE on the fetus is unknown. Females of childbearing potential must have a blood test within 7 days prior to enrollment to rule out pregnancy - must be repeated if not within 7 days of treatment initiation
• History of central nervous system (CNS) malignancy or symptoms of active CNS disease
• A family history of long QT syndrome or with a corrected QT (QTc) interval > 480 msec at screening
• Currently taking medications known to prolong QT/QTc interval as the potential risk of QT/QTc prolongation is unknown in humans.
• A candidate for potentially curative therapy, including hematopoietic cell transplant
• Unwilling to remain within a 90 minute drive of the study center through at least Day 29

Where it is running

• Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota, United States
• University of Wisconsin Clinical Science Center — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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