Trials / Terminated
TerminatedNCT03214666
GTB-3550 Tri-Specific Killer Engager (TriKE®) for High Risk Hematological Malignancies
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
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- GT Biopharma, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-01-01
- Primary completion
- 2021-08-02
- Completion
- 2021-09-29
- First posted
- 2017-07-11
- Last updated
- 2022-11-10
- Results posted
- 2022-11-10
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03214666. Inclusion in this directory is not an endorsement.