HaemaLogiX has opened patient enrolment for its phase 1 Koala clinical trial at the Peter MacCallum Cancer Centre, marking the first human study of the company’s KMCAR T‑cell therapy for relapsed or refractory kappa‑restricted multiple myeloma.
The study activation follows clinical trial approval from Australia’s Therapeutic Goods Administration and ethics clearance, enabling the shift from pre clinical development into clinical evaluation. The dose‑escalation trial will assess the safety and early efficacy of KMCAR T cell, an autologous CAR‑T therapy engineered to target the tumour‑specific Kappa Myeloma Antigen, which is found only on myeloma cells and not on healthy immune cells.
According to HaemaLogiX, this selectivity may allow effective tumour killing while preserving normal immune function, setting the therapy apart from currently approved BCMA‑directed CAR‑T products. KMCAR T cell is derived from the company’s KappaMab antibody platform, which has been validated across multiple phase 1, 2a and 2b studies with a favourable safety profile. Pre clinical work conducted with Peter Mac demonstrated specific and durable killing of KMA‑positive tumour cells.
Dr Rosanne Dunn, Chief Scientific Officer and Co‑Founder of HaemaLogiX, said: “This milestone reflects years of scientific collaboration and commitment to developing a targeted, tumour specific approach for patients with relapsed or refractory multiple myeloma. We are excited to see our KMCAR T cell therapy progress into clinical testing and look forward to the insights the KOALA study will generate.”
Dr Chris Baldwin, CEO of HaemaLogiX, said: “The commencement of patient screening and enrolment in the KOALA clinical trial represents a significant milestone at a critical time in the evolution of CAR-T therapies for multiple myeloma.” He added: “Our KMCAR T-cell therapy is differentiated by its ability to target the tumour specific KMA antigen, and we believe it has the potential to further broaden the therapeutic impact of CAR-T approaches in multiple myeloma.”
Multiple myeloma remains the second most common haematological cancer worldwide, with most patients eventually relapsing despite therapeutic advances.
