HaemaLogiX has treated the first patient with its KMCAR T-cell therapy as part of the Phase I KOALA clinical trial for relapsed or refractory kappa-restricted multiple myeloma.
The trial is being conducted at the Peter MacCallum Cancer Centre in Australia.
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The treatment was well tolerated and no serious adverse events were reported. A second patient has been enrolled and is expected to receive treatment at a higher dose in the near future.
The study represents the first time KMCAR T-cell immunotherapy has been administered to humans. The therapy targets the Kappa Myeloma Antigen (KMA), which is found only on malignant plasma cells.
KMCAR T-cell therapy involves modifying a patient’s own immune cells to recognise and eliminate only those cells expressing KMA, while preserving normal immune function.
HaemaLogiX states that current therapies may impact healthy immune cells as well as cancerous ones, but KMCAR T-cell treatment is designed to avoid this.
The trial’s primary aim is to assess safety and early signs of efficacy in patients who no longer respond to standard treatments and are not eligible for other chimeric antigen receptor T-cell (CAR-T) therapies.
Manufacture of the KMCAR T cells is carried out 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.
HaemaLogiX chief scientific officer Dr Rosanne Dunn 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.
“Seeing this work translate from the laboratory into human trials with positive safety data is a very important step forward for our immunotherapy programmes. Our thanks to the first patient for joining the study and to our colleagues at Peter MacCallum Centre of Excellence for Cellular Immunotherapy for their commitment to progressing this important study.”
Multiple myeloma is a form of blood cancer involving abnormal proliferation of plasma cells in bone marrow.
The KMCAR T-cell therapy tested in this trial is based on HaemaLogiX’s proprietary KappaMab antibody platform, which has been evaluated in previous Phase I, IIa and IIb studies.
