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Brief Title: GTB-3550 Tri-Specific Killer Engager (TriKE®) for High Risk Hematological Malignancies
Official Title: GTB-3550 (CD16/IL-15/CD33)Tri-Specific Killer Engager (TriKE®) for the Treatment of High Risk Myelodysplastic Syndromes, Refractory/Relapsed Acute Myeloid Leukemia and Advanced Systemic Mastocytosis
Study ID: NCT03214666
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, United States
University of Wisconsin Clinical Science Center, Madison, Wisconsin, United States
Name: Mark B Juckett, MD
Affiliation: Masonic Cancer Center, University of Minnesota
Role: PRINCIPAL_INVESTIGATOR