Jasper Therapeutics has dosed the first patient in a Phase I clinical trial of briquilimab to treat lower-risk myelodysplastic syndrome (LR-MDS).
The single-arm, open-label study will be conducted at Moffitt Cancer Center in Tampa, Florida.
It will assess the tolerability and safety of the therapeutic as second-line therapy in subjects with LR-MDS.
With a 3+3 dose escalation design, the study will identify a recommended Phase II dose and the maximum tolerated dose or optimal biologic dose of briquilimab.
Jasper Therapeutics president and CEO Ronald Martell said: “To date, the potential of briquilimab has been clinically assessed across five transplant indications and we are excited to explore its potential as a treatment option for a chronic disease such as LR-MDS.
“This trial underscores our commitment to improving outcomes and quality of life for patients with rare and chronic diseases driven by mast and stem cells.”
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The study intends to recruit up to 30 LR-MDS patients with documented cytopenia such as thrombocytopenia, and red blood cell transfusion dependence.
They will receive briquilimab every 56 days for four consecutive cycles.
Jasper Therapeutics chief medical officer Edwin Tucker said: “While certain treatments could be employed to manage the symptoms, they do not typically target diseased cells or offer a comprehensive therapeutic approach.
“With its compelling therapeutic potential in targeting c-Kit, briquilimab holds great promise in lower-risk MDS and could provide a profound benefit for patients in dire need of new therapies.”
Briquilimab, a monoclonal antibody, is also used in the treatment of intermediate risk MDS, and chronic spontaneous urticaria.
It also acts as a conditioning agent for stem cell transplants for severe combined immunodeficiency, Fanconi anemia, and sickle cell disease.