HM2023-05: GTB-3650 Trike for High Risk MDS and R/R AML
Summary
This is a Phase I dose finding study of GTB-3650 (anti-CD16/IL-15/anti-CD33) Tri-Specific Killer Engager (TriKE®) for the treatment of select CD33-expressing refractory/relapsed myeloid malignancies in adults ≥ 18 years of age who are not a candidate for potentially curative therapy, including hematopoietic stem cell transplantation, and are refractory to, intolerant of, or ineligible for therapy options that are known to provide clinical benefit. The hypothesis is GTB-3650 TriKE will induce natural killer (NK) cell function by targeting malignant cells, as well as, CD33+ myeloid derived suppressor cells (MDSC) which contribute to a tumor induced immunosuppression. Because CD16 is the most potent activating receptor on NK cells, this single agent may induce a targeted antiCD33+ tumor response
Timeline
- Start
- 2024-11-19
- Primary completion
- 2027-03-30
- Completion
- 2027-10-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GTB-360 | Other / unclassified | 1.25 ug/kg | Other |
| Subject | GTB-360 | Other / unclassified | 2.5 ug/kg | Other |
| Subject | GTB-360 | Other / unclassified | 5 ug/kg | Other |
| Subject | GTB-360 | Other / unclassified | 10 ug/kg | Other |
| Subject | GTB-360 | Other / unclassified | 15 ug/kg | Other |
| Subject | GTB-360 | Other / unclassified | 22 ug/kg | Other |
| Subject | GTB-360 | Other / unclassified | 25 ug/kg | Other |
| Subject | GTB-360 | Other / unclassified | 33 ug/kg | Other |
| Subject | GTB-360 | Other / unclassified | 50 ug/kg | Other |
| Subject | GTB-360 | Other / unclassified | 100 ug/kg | Other |