Biotechnology company HaemaLogiX has begun patient enrolment for a Phase I study evaluating a therapy for multiple myeloma. 

The KOALA study is a Phase I 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 could 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. Pre‑clinical studies provided proof‑of‑concept for the CAR‑T modality, showing specific and durable killing of KMA‑positive tumour cells. 

“This milestone reflects years of scientific collaboration and commitment to developing a targeted, tumour‑specific approach for patients with relapsed or refractory multiple myeloma,” said Dr Rosanne Dunn, Chief Scientific Officer and Co-Founder of HaemaLogiX. 

“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.” 

“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,” added Dr Chris Baldwin, CEO of HaemaLogiX.  

“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.”