Colorised scanning electron micrograph of a natural killer cell from a human donor. Credit: NIAID.

US-based GT Biopharma has secured the necessary authorisations to conduct a Phase I clinical trial of its first tri-specific killer engager (TriKE) candidate, GTB-3550, at the University of Minnesota.

GTB-3550 is a single-chain, tri-specific scFv recombinant fusion protein conjugate with IL-15 as a crosslinker. It is designed to bind to natural killer (NK) cells and direct them, specifically to leukaemia cells.

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The company intends to investigate the drug candidate in CD33 positive leukaemias.

During the single centre Phase I trial, GTB-3550 will be tested in up to 60 patients with CD33-expressing high risk acute myelogenous leukaemia (AML), myelodysplatic syndrome (MDS) or advanced systemic mastocytosis.

The therapeutic will be administered as a single course in three weekly treatment blocks. Each block will involve four sequential 24-hour continuous GTB-3550 infusions, followed by a break of 72 hours.

“Success with GTB-3550 in this Phase I study will allow us to further investigate the TriKE in a larger number of cancer patients.”

Investigators will perform a bone marrow biopsy to evaluate disease response between day 21 and day 42 after the start of the first infusion.

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Follow-up for response and survival will be carried out until six months from the beginning of the therapy.

Primary objective of the Phase I dose-finding portion of the trial will be the maximum tolerated dose (MTD) of GTB-3550.

The Phase II extended part of the trial will measure GTB-3550’s potential efficacy as the primary objective.

Patients experiencing clinical benefit without unacceptable side effects may be enrolled into a second course of the drug candidate.

GT Biopharma CEO Anthony Cataldo said: “The clinical trials team at the University of Minnesota are excited to commence the Phase I trial testing this novel immunotherapeutic agent, GTB-3550.

“The pre-clinical data are compelling, and success with GTB-3550 in this Phase I study will allow us to further investigate the TriKE in a larger number of cancer patients.”

The company’s TriKE platform produces moieties that leverage and boost a patient’s own NK cells.

GT Biopharma portfolio also includes tetra-specific killer engager (TetraKE) and bi-specific antibody-drug conjugate (ADC) technology platforms for the development of immuno-oncology medicines.