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

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

January 1, 2020

Primary Completion Date

August 2, 2021

Study Completion Date

September 29, 2021

Conditions
High-risk Myelodysplastic SyndromesAcute Myelogenous LeukemiaSystemic MastocytosisMast Cell Leukemia
Interventions
DRUG

GTB-3550 TriKE® Phase I

"The 1st two patients will be assigned Dose Level 1. The study statistician will assign each new cohort of 2 patients to the most appropriate dose level based on updated toxicity probabilities.~* Dose Level 1 - 5 μg/kg/day~* Dose Level 2 - 10 μg/kg/day~* Dose Level 3 - 25 μg/kg/day~* Dose Level 4 - 50 μg/kg/day~* Dose Level 5 - 100 μg/kg/day~* Dose Level 6 - 150 μg/kg/day~* Dose Level 7 - 200 μg/kg/day"

DRUG

GTB-3550 TriKE® Phase II

Patients will receive the maximum tolerated dose (MTD) established during Phase I with monitoring guidelines to stop the study early for excessive toxicity.

Trial Locations (2)

53792

University of Wisconsin Clinical Science Center, Madison

55455

Masonic Cancer Center, University of Minnesota, Minneapolis

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GT Biopharma, Inc.

INDUSTRY