GTB-3550 (CD16/IL-15/CD33) Tri-Specific Killer Engager (TriKE™) for High Risk Heme Malignancies
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|ClinicalTrials.gov Identifier: NCT03214666|
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : June 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|High-risk Myelodysplastic Syndromes Acute Myelogenous Leukemia Systemic Mastocytosis Mast Cell Leukemia||Drug: GTB-3550 TriKE™ Phase I Drug: GTB-3550 TriKE™ Phase II||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||January 1, 2020|
|Estimated Primary Completion Date :||February 1, 2024|
|Estimated Study Completion Date :||August 1, 2025|
Experimental: GTB-3550 TriKE™ (Phase I: Dose Finding Component)
Patients receive a single course of GTB-3550 TriKE™ at their assigned dose as 3 weekly treatment blocks. Each block consists of four consecutive 24 hour continuous infusions (over approximately 96 hours) of GTB-3550 TriKE™ followed by a 72 hour break after Block #1 and #2. All treatment is given as an inpatient. The assigned dose will be calculated on a weight obtained within 5 days prior to or on day of the 1st dose. The dose is not be recalculated for subsequent treatment blocks.
Drug: GTB-3550 TriKE™ Phase I
Bolus Test Dose: 20% of Daily Continuous Infusion Dose.
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.
Other Name: CD16/IL-15/CD33
Experimental: GTB-3550 TriKE™ Only (Phase II: Extended Component)
The treatment schedule is identical to the dose finding component. The extended component uses a Simon's MiniMax two-stage design for continued enrollment using the maximum tolerated dose (MTD) established during Phase I with monitoring guidelines to stop the study early for excessive toxicity.
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.
Other Name: CD16/IL-15/CD33
- Phase I Maximum Tolerated Dose (MTD) of GTB-3550 TriKE™ Finding [ Time Frame: Day 28 ]To identify the maximum tolerated dose (MTD) of GTB-3550 TriKE™ defined as the dose level that most closely corresponds to a dose limiting toxicity rate (DLT) of 20%
- Phase II Incidence of complete and partial remission due to GTB-3550 TriKE™ treatment [ Time Frame: Day 42 ]The incidence of clinical response by Day 42 after the start of the 1st infusion.
- Incidence of GTB-3550 TriKE™ Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Day 28 ]The incidence of unexpected events in relation to GTB-3550 TriKE™
- Overall Survival (OS) [ Time Frame: 6 Months ]Incidence of survival of patients treated on this study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03214666
|Contact: Jeffrey S Miller, MDemail@example.com|
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Timothy Krepski 612-273-2800 firstname.lastname@example.org|
|Principal Investigator: Erica D Warlick, MD|
|Principal Investigator:||Erica D Warlick, MD||Masonic Cancer Center, University of Minnesota|