GT Biopharma has just announced that their Phase 1 clinical trial for Mastocytosis, Myelodysplastic Syndrome (MDS), and Acute Myeloid Leukemia (AML) has been authorized to begin.
Although this investigation had previously received approval from the FDA, other authorizations were also required. Since this trial is being conducted at the University of Minnesota permission was needed from the school’s IRB as well as their Cancer Protocol Review Committee. With these new authorizations in hand, the trial is finally set to commence.
This trial is called TriKE and it will be examining GTB-3550 as a treatment for the above three conditions.
GTB-3550
GTB-3550 is a Tri-specific Killer Engager product, hence the name TriKE. It is a fusion protein made up of anti-CD16 antibodies, anti-CD33 antibodies, and IL-15. It binds to natural killer (NK) cells and enhances their activity and ability to kill (thanks to the IL-15).
Researchers think that GTB-3550 either on its own, or combined with traditional chemotherapy, could be valuable for these patient populations. It would be easy to use, safe, and cost-effective.
TriKE
The Principal Investigator of this trial is Erica Warlick, Associate Professor at the university. She, along with her team, hope to enroll 60 patients with MDS, advanced systemic mastocystosis, and relapsed or refractory AML who are all CD33-expressing. It’s primary objective is to uncover the maximum tolerated dose of the treatment.
All patients will receive a course of GTB-3550 by infusion in 3 weekly treatment blocks. The participants will be examined up until 6 months following treatment to assess response and survival. Response will be measured by a bone marrow biopsy.
If this trial is successful, researchers hope to further their investigation of GTB-3550 with a larger number of patients. They will also conduct a Phase 2 study which will examine the treatment’s efficacy utilizing remission rates (partial and complete).
Patients who experience clinical benefit without serious side effects will be considered to receive a 2nd course of the therapy on compassionate basis.
Hopefully we will see positive results announced from this trial in the near future!
You can read more about this upcoming trial here.
