SYDNEY, Australia, August 26, 2026
HaemaLogiX Ltd has announced a key clinical development milestone with the first patient successfully dosed with KMCAR™ T-cell therapy in the Phase 1 KOALA trial, advancing the company’s investigational cell therapy into first-in-human clinical evaluation for patients with relapsed/refractory kappa-restricted multiple myeloma. The initial patient was monitored following treatment, with the therapy reported as well tolerated and without serious adverse events. A second patient has been enrolled and is expected to receive treatment at a higher dose level. The milestone represents an important step for HaemaLogiX as it evaluates whether its proprietary KMCAR™ T-cell technology can provide a more selective cellular immunotherapy approach for patients whose disease has stopped responding to standard treatment options. The KOALA study is being conducted at the Peter MacCallum Cancer Centre in Australia and is designed to generate early clinical information on the safety and preliminary efficacy of the investigational therapy.
KOALA Trial Evaluates Targeted KMCAR™ T-Cell Therapy
The Phase 1 KOALA trial is a dose-escalation study evaluating the safety and preliminary efficacy of HaemaLogiX’s proprietary KMCAR™ T-cell technology (PMCC-COE-KMA) in heavily treated patients with multiple myeloma who have limited therapeutic options and are not eligible for other CAR-T therapies. The treatment uses a patient’s own T cells, which are collected from the blood and genetically engineered to recognize the Kappa Myeloma Antigen (KMA) before being returned to the patient. KMA is described by HaemaLogiX as a tumor-specific receptor found on malignant kappa-type plasma cells and absent from healthy immune cells. This targeting strategy is central to the company’s clinical development approach, with KMCAR™ designed to eliminate malignant myeloma cells while preserving healthy immune cells. The second patient’s planned treatment at a higher dose will allow investigators to continue the trial’s dose-escalation assessment while monitoring safety and potential biological activity.
KMA Targeting Could Differentiate KMCAR™ From Existing CAR-T
A major focus of the KMCAR™ clinical program is the potential for selective tumor targeting in multiple myeloma. Existing BCMA-directed CAR-T approaches can affect both malignant plasma cells and healthy B-cell populations, potentially contributing to prolonged immune suppression and infection risk. HaemaLogiX is developing KMCAR™ around a different target, with the therapy intended to recognize KMA-positive malignant plasma cells while sparing normal immune cells. The company believes this tumor-selective mechanism could potentially address an important limitation associated with current cellular therapies. However, the first patient safety observation remains early clinical evidence, and the available information does not yet establish efficacy, durability of response, or whether KMCAR™ will ultimately demonstrate a meaningful safety advantage over approved CAR-T therapies. Those questions will require additional patients, longer follow-up and results from subsequent clinical development. KMCAR™ is derived from HaemaLogiX’s proprietary KappaMab™ antibody technology, which the company says has previously been evaluated in Phase 1, Phase 2a and Phase 2b studies.
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HaemaLogiX Moves Toward Next Clinical Milestones
The first dosing milestone strengthens HaemaLogiX’s broader strategy of developing KMA- and LMA-targeted immunotherapies for blood cancers and B-cell diseases. The KOALA study is being conducted at the Centre of Excellence in Cellular Immunotherapy at Peter MacCallum Cancer Centre, while Cell Therapies Pty Ltd is manufacturing the KMCAR™ T cells. Cell Therapies operates a TGA-licensed Good Manufacturing Practice (GMP) facility and is partnered with Peter MacCallum Cancer Centre for cellular therapy manufacturing. Multiple myeloma remains a significant clinical challenge because most patients eventually relapse or become refractory to available treatments despite advances in therapy. Against this background, HaemaLogiX is evaluating whether a more selective CAR-T strategy can improve the therapeutic balance between cancer-cell elimination and preservation of immune function. The KOALA trial is registered as NCT07541391, and upcoming patient dosing and dose-escalation data will be important for determining whether KMCAR™ can progress beyond this initial first-in-human evaluation.
Source: HaemaLogiX press relese
