First patient dosed in KOALA CAR-T trial for multiple myeloma
28 Aug 2026
Cell Therapies Pty Ltd has announced the successful manufacture and release of the first clinical dose for the KOALA trial*, a first-in-human study evaluating a novel CAR T-cell therapy for patients with relapsed or refractory multiple myeloma.
The first patient has now been dosed with PMCC-COE-KMA, an investigational CAR T-cell therapy being developed by Peter MacCallum Cancer Centre's Centre of Excellence in Cellular Immunotherapy (CoE) and licensed by Australian biotechnology company HaemaLogiX Ltd.
While several CAR T-cell therapies are approved for certain blood cancers, PMCC-COE-KMA is the first investigational therapy specifically designed to target KMA in multiple myeloma.
The KOALA trial will evaluate the safety and efficacy of PMCC-COE-KMA in patients with multiple myeloma whose disease is no longer responding to standard therapies and who are not currently eligible for other CAR T-cell treatments.
PMCC-COE-KMA is designed to target kappa myeloma antigen (KMA), a receptor found on multiple myeloma cells and absent from healthy immune cells. Researchers hope this differentiated approach may enable a more targeted anti-myeloma effect while reducing treatment-related toxicities.
As the manufacturing partner for the trial, Cell Therapies is responsible for producing clinical doses of PMCC-COE-KMA at its GMP-licensed cell therapy manufacturing facility in Melbourne. The company's specialized manufacturing facility is co-located with Peter Mac, providing a streamlined pathway from research and development through to clinical delivery.
Cell Therapies CEO Dr. Bev Menner said the first patient dosing represents an important milestone for Australian-developed cell therapies. "The successful treatment of the first patient in the KOALA trial is a significant achievement for everyone involved and demonstrates the power of bringing together world-class research, clinical expertise and advanced manufacturing capabilities."
"This milestone highlights the value of Australia's cell therapy ecosystem and showcases how partnerships between researchers, biotechnology companies and specialized manufacturers can accelerate the development of next-generation therapies."
The Centre of Excellence in Cellular Immunotherapy and HaemaLogiX collaborated to advance PMCC-COE-KMA from early-stage development through to approval by the Therapeutic Goods Administration (TGA) to proceed into clinical testing.
Dr. Rosanne Dunn, Chief Scientific Officer at 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.”
*The KOALA trial is led by Principal Investigator Dr. Mark Dowling, and patient enrolment is ongoing.
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What is the KOALA trial evaluating for relapsed or refractory multiple myeloma?
The first-in-human KOALA trial is evaluating the safety and efficacy of PMCC-COE-KMA, an investigational CAR T-cell therapy, in patients whose multiple myeloma no longer responds to standard therapies and who are not currently eligible for other CAR T-cell treatments.
How does PMCC-COE-KMA target multiple myeloma cells?
PMCC-COE-KMA targets kappa myeloma antigen (KMA), a receptor found on multiple myeloma cells but absent from healthy immune cells. Researchers hope this differentiated approach can produce a more targeted anti-myeloma effect while reducing treatment-related toxicities.
Who developed and manufactured the PMCC-COE-KMA CAR T-cell therapy?
Peter MacCallum Cancer Centre’s Centre of Excellence in Cellular Immunotherapy developed PMCC-COE-KMA, which is licensed by HaemaLogiX Ltd. Cell Therapies manufactured the first clinical dose at its GMP-licensed Melbourne facility, co-located with Peter Mac.