CD16/IL-15/CD33 Tri-Specific Killer Engagers (TriKEs) for High Risk Heme Malignancies
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|ClinicalTrials.gov Identifier: NCT03214666|
Recruitment Status : Not yet recruiting
First Posted : July 11, 2017
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|High-risk Myelodysplastic Syndromes Acute Myelogenous Leukemia Systemic Mastocytosis Mast Cell Leukemia||Drug: 161533 Trike Phase I Drug: 161533 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:||CD16/IL-15/CD33 (161533) Tri-Specific Killer Engagers (TriKEs) for the Treatment of High Risk Myelodysplastic Syndromes, Refractory/Relapsed Acute Myeloid Leukemia and Advanced Systemic Mastocytosis|
|Estimated Study Start Date :||January 1, 2020|
|Estimated Primary Completion Date :||February 1, 2024|
|Estimated Study Completion Date :||August 1, 2025|
Experimental: 161533 TriKE (Phase I: Dose Finding Component)
Patients receive a single course of 161533 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 161533 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: 161533 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: 161533 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: 161533 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 161533 TriKE Finding [ Time Frame: Day 28 ]To identify the maximum tolerated dose (MTD) of 161533 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 161533 TriKE treatment [ Time Frame: Day 42 ]The incidence of clinical response by Day 42 after the start of the 1st infusion.
- Incidence of 161533 TriKE Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Day 28 ]The incidence of unexpected events in relation to 161533 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: Timothy Krepskifirstname.lastname@example.org|
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Erica D Warlick, MD||Masonic Cancer Center, University of Minnesota|