HaemaLogiX, biotech company based in Australia, has treated the first patient with its investigational KMCAR T-cell therapy in a Phase I clinical trial evaluating the treatment in patients with relapsed or refractory kappa-restricted multiple myeloma.

The KOALA Phase I trial is being conducted at the Peter MacCallum Cancer Centre in Australia and marks the first time KMCAR T-cell immunotherapy has been administered to humans.

According to HaemaLogiX, the first patient tolerated the treatment well, with no serious adverse events reported. A second patient has since been enrolled and is expected to receive KMCAR T-cell therapy at a higher dose.

KMCAR T-cell therapy is designed to target the Kappa Myeloma Antigen (KMA), a target found on malignant plasma cells. The approach involves genetically modifying a patient’s own T cells to recognise and eliminate cells expressing KMA while aiming to preserve healthy immune cells.

The company said this selective targeting could potentially address a limitation of some existing cancer therapies, which can affect healthy immune cells alongside malignant cells and contribute to immunodeficiency.

The Phase I study is primarily designed to evaluate the safety, tolerability and early signs of efficacy of KMCAR T-cell therapy in patients whose disease has stopped responding to standard treatments and who are not eligible for other CAR-T therapies.

Dr Rosanne Dunn, Chief Scientific Officer, HaemaLogiX, said, “We are delighted with the encouraging results from the first safely treated patient, and very pleased to be moving forward to dosing the second patient at a higher dose of KMCAR T-cell therapy.”

“Multiple myeloma is the world’s second-most common blood cancer, and there is a significant need for therapies that do not cause immunodeficiency, which may result in life-threatening infections,” Dunn added.

Manufacturing of the KMCAR T cells is being undertaken by Cell Therapies, which operates a Therapeutic Goods Administration-licensed good manufacturing practice facility and is partnered with the Peter MacCallum Cancer Centre’s Centre of Excellence in Cellular Immunotherapy.

Multiple myeloma is a blood cancer characterised by the abnormal proliferation of plasma cells in the bone marrow. Despite advances in treatment, patients with relapsed or refractory disease continue to face significant therapeutic challenges.

The KMCAR T-cell programme builds on HaemaLogiX’s proprietary KappaMab antibody platform, which has previously been evaluated in Phase I, IIa and IIb clinical studies.

The company expects the ongoing KOALA trial to provide initial clinical evidence on whether the KMA-targeted CAR-T approach can offer a more selective treatment option for patients with kappa-restricted multiple myeloma.