HaemaLogiX announced that the first patient in the Phase-1 KOALA trial of KMCAR has been treated at the Peter MacCallum Cancer Centre in Melbourne, Australia. The patient tolerated the first infusion well, the company said, with no serious adverse events. The trial targets patients with kappa-restricted, relapsed or refractory multiple myeloma who have failed standard treatments.
How the Therapy Works
CAR-T cell therapy extracts a patient's T cells, engineers them to recognize cancer cells, and reinfuses them. KMCAR programs T cells to recognize the kappa myeloma antigen, a receptor that HaemaLogiX says appears only on kappa-type myeloma cells and is absent from healthy immune cells. Before CAR-T infusion, patients receive lymphodepleting conditioning chemotherapy. Unlike BCMA-directed therapies, which target an antigen also found on healthy plasma cells, KMCAR targets a myeloma-specific antigen.
Multiple myeloma is a blood cancer that begins in bone marrow plasma cells. Despite treatment advances, most patients eventually relapse and become resistant to available therapies. Globally, roughly 188,000 people are diagnosed yearly and about 543,000 live with the disease, according to WHO/Globocan estimates cited by HaemaLogiX. Forty-two percent of patients die within five years of diagnosis.
Approved BCMA-directed CAR-T therapies carry a risk of reducing healthy, antibody-producing plasma cells, increasing susceptibility to severe infections like pneumonia.
What the Announcement Means and What Remains Unknown
The Australian Medicines Authority, TGA, approved the clinical trial in March 2026. The ethics approval was still pending at that time. Patient enrollment opened in May 2026. Cell Therapies Pty Ltd, a GMP-licensed facility associated with the center, manufactured the KMCAR cells. KOALA is an open-label, sequential Phase-1 trial with an estimated 12 participants. A second patient was already enrolled and scheduled for a higher dose. This represents the first human application against a target that is neither BCMA nor GPRC5D in a 12-patient trial.
Where CAR-T Therapies Currently Focus
KMCAR derives from HaemaLogiX's proprietary KappaMab antibody technology, studied in Phase 1, 2a, and 2b clinical trials with a favorable safety profile and sustained patient responses. The CAR-T cell therapy itself was tested in preclinical animal models of multiple myeloma, which showed specific and sustained killing of KMA-positive tumor cells. Experience with CAR-T therapy in myeloma exists for BCMA-directed agents, which achieve high response rates in heavily pretreated patients but damage protective immune cells and increase infection risk.
What the Trial Will Show
An estimated 12 participants are planned. The primary completion date is September 2028, with study completion in January 2030. Primary endpoints include safety, maximum tolerated dose, and the manufacturability of suitable CAR-T product. Secondary endpoints include objective response rate, progression-free survival, and overall survival. If clinical trials confirm the hoped-for immune protection, it could represent an important advance in myeloma treatment, said Simon Harrison, director of the Centre of Excellence in Cellular Immunotherapy at Peter Mac.