GTB-3550 Tri-Specific Killer Engager (TriKE®) for High Risk Hematological Malignancies
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.
Timeline
- Start
- 2020-01-01
- Primary completion
- 2021-08-02
- Completion
- 2021-09-29
Outcome
Outcome not reported
Stopped: “Development of GTB-3550 halted due to development of the second generation camelid nanobody TriKE drug product, GTB-3650.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GTB-3550 | Other / unclassified | 5 ug/kg | — |
| Subject | GTB-3550 | Other / unclassified | 10 ug/kg | — |
| Subject | GTB-3550 | Other / unclassified | 25 ug/kg | — |
| Subject | GTB-3550 | Other / unclassified | 50 ug/kg | — |
| Subject | GTB-3550 | Other / unclassified | 100 ug/kg | — |
| Subject | GTB-3550 | Other / unclassified | 150 ug/kg | — |
| Subject | GTB-3550 | Other / unclassified | 200 ug/kg | — |