Posted On: 19 May 2026
KEY POINTS
MELBOURNE, 19 May 2026 – HaemaLogiX Ltd is pleased to announce that the KOALA Phase 1 clinical trial is now active and open to patient enrolment at the Peter MacCallum Cancer Centre. The study targets multiple myeloma, the second most common blood cancer worldwide1.
This achievement follows the successful receipt of Clinical Trial Approval (CTA) from Australia’s Therapeutic Goods Administration (TGA) and ethics approval for the study, enabling the transition from pre‑clinical development into clinical evaluation.
The KOALA study is a Phase 1 dose‑escalation trial assessing the safety and preliminary efficacy of KMCAR™ T‑cell, a novel autologous CAR‑T therapy targeting the Kappa Myeloma Antigen (KMA) - a tumour‑specific receptor found only on myeloma cells and absent from healthy immune cells. This unique specificity has the potential to deliver effective tumour killing, while sparing normal immune function, distinguishing KMCAR™ T‑cell therapy from currently approved BCMA‑directed CAR‑T therapies.
KMCAR™ T-cell therapy harnesses and genetically modifies a patient’s own T cells to recognise and destroy cancerous plasma cells that express KMA. The therapy is derived from HaemaLogiX’s proprietary KappaMab™ antibody technology, which has been validated in multiple Phase 1, 2a and 2b clinical trials, demonstrating a favourable safety profile and durable patient responses. Pre‑clinical studies conducted jointly by HaemaLogiX and Peter Mac provided compelling proof‑of‑concept for the CAR‑T modality, showing specific and durable killing of KMA‑positive tumour cells.
Dr Rosanne Dunn, Chief Scientific Officer and Co-Founder of HaemaLogiX, said:
"This milestone reflects years of scientific collaboration and commitment to developing a targeted, tumour‑specific approach for patients with relapsed or refractory multiple myeloma. We are excited to see our KMCAR™ T‑cell therapy progress into clinical testing and look forward to the insights the KOALA study will generate."
Dr Chris Baldwin, CEO, HaemaLogiX, said:
“The commencement of patient screening and enrolment in the KOALA clinical trial represents a significant milestone at a critical time in the evolution of CAR-T therapies for multiple myeloma. Momentum in the field continues to build, highlighted by the Australian Government’s recent decision to provide eligible patients with free access to Carvykti - a BCMA‑targeted CAR‑T cell therapy - reinforcing the growing importance of this treatment class. Our KMCAR™ T-cell therapy is differentiated by its ability to target the tumour‑specific KMA antigen, and we believe it has the potential to further broaden the therapeutic impact of CAR-T approaches in multiple myeloma.”
About Multiple Myeloma
Multiple myeloma is a blood cancer arising from plasma cells in the bone marrow. Despite significant advances in treatment, most patients eventually relapse and become refractory to available therapies. CAR-T cell therapy has emerged as a transformative treatment option for blood cancers, with BCMA-directed products showing remarkable response rates in heavily pre-treated patients. However, they also have the characteristic of damaging protective immune cells, leaving patients seriously at risk of infections such as pneumonia.
Multiple myeloma is the second most common haematological cancer worldwide. In 2022, the World Health Organisation (WHO)/Global Cancer Observatory (Globocan) estimated that approximately 543,000 people live with multiple myeloma globally, and approximately 188,000 new cases of multiple myeloma were diagnosed each year globally, with approximately 121,400 deaths. Approximately, 42% of patients will die within five years from time of diagnosis[2].
KOALA Study Background
The KOALA study is being conducted at Peter Mac’s Centre of Excellence in Cellular Immunotherapy, with Cell Therapies Pty Ltd manufacturing the KMCAR™ T‑cells. Cell Therapies Pty Ltd – which is partnered with Peter Mac – is a TGA licensed Good Manufacturing Practise (GMP) facility, supporting seamless transition to a potential future Phase 1b study of this novel therapy, and beyond.
The KOALA trial is registered on ClinicalTrials.gov (Identifier: NCT07541391): https://clinicaltrials.gov/study/NCT07541391.
-ENDS-