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

NCT03214666 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-11-10

Study results available
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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.

Conditions

  • High-risk Myelodysplastic Syndromes
  • Acute Myelogenous Leukemia
  • Systemic Mastocytosis
  • Mast 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.

Sponsors & Collaborators

  • GT Biopharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark B Juckett, MD · Masonic Cancer Center, University of Minnesota

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2021-08-02
Completion
2021-09-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03214666 on ClinicalTrials.gov