HaemaLogiX, the biotechnology company, confirmed that the initial patient in its Phase 1 KOALA study experienced no serious adverse events following an infusion of KMCAR T-cell therapy.
The dose-escalation trial, conducted at the Peter MacCallum Cancer Centre, assesses the safety and early efficacy of the treatment in patients with relapsed or refractory kappa-restricted multiple myeloma.
Multiple myeloma is the second-most common blood cancer in the world, with roughly 188,000 new cases diagnosed annually and an estimated 543,000 people living with the disease.
Approximately 42% of patients die within five years of diagnosis, and most existing CAR-T therapies frequently weaken the patient's immune system by destroying healthy cells alongside malignant ones.
The experimental KMCAR T-cell therapy is designed to overcome this limitation by targeting the Kappa Myeloma Antigen (KMA), a tumor-specific receptor found only on malignant plasma cells.
To deliver the therapy, technicians harvest T-cells from the patient's own blood, genetically modify them to recognize KMA, and reinfuse them to attack cancer cells while preserving protective immune function.
The treatment is derived from the company's proprietary KappaMab antibody technology, which previously demonstrated safety and durable responses across Phase 1, Phase 2a, and Phase 2b clinical trials.
Following the successful monitoring of the first patient, investigators have enrolled a second patient who will receive a higher dose of the immunotherapy.
Professor Simon Harrison, director of the Centre of Excellence in Cellular Immunotherapy at the Peter MacCallum Cancer Centre, said the therapy provides a targeted approach that could reduce immune system damage compared to existing treatments.
Dr Rosanne Dunn, chief scientific officer at HaemaLogiX, stated that advancing the therapy into human trials with initial safety data is an important step forward in addressing the need for treatments that avoid life-threatening immunodeficiency.
Cell Therapies Pty Ltd, a Good Manufacturing Practice (GMP) facility partnered with the Peter MacCallum Cancer Centre, is manufacturing the KMCAR T-cells for the trial.
The KOALA study is officially registered on ClinicalTrials.gov under the identifier NCT07541391.
