HaemaLogiX Doses First Patient in Phase 1 Trial of Kappa-Targeted CAR-T Therapy KMCAR for Multiple Myeloma

HaemaLogiX announced that the first patient has been safely dosed in its Phase 1 KOALA trial of KMCAR T-cell therapy, with the treatment reported as well tolerated and no serious adverse events observed following the initial infusion.¹ A second patient has since enrolled and is set to be treated at a higher dose level as the dose-escalation study continues.¹ The trial, being conducted at Peter MacCallum Cancer Centre, is the first in-human study of KMCAR, evaluating patients with relapsed/refractory kappa-restricted multiple myeloma who are no longer responding to standard treatment and are not eligible for other CAR-T therapies.¹

How does KMCAR work, and how does it differ from existing CAR-T therapies?

KMCAR is designed to target the Kappa Myeloma Antigen (KMA), a tumor-specific receptor HaemaLogiX describes as present only on kappa-type malignant plasma cells and absent from healthy immune cells.¹ This is intended to differentiate it from most currently approved BCMA-directed CAR-T therapies, which target antigens present on both cancerous and healthy cells, a mechanism the company says can weaken immune function and lead to opportunistic infections.¹ Delivery involves harvesting and genetically modifying a patient's own T cells to create KMCAR T-cells, which are then infused back into the patient to recognize and eliminate KMA-expressing plasma cells while sparing healthy immune tissue.¹ KMCAR is derived from HaemaLogiX's proprietary KappaMab antibody technology, which the company states has been evaluated across phase 1, 2a, and 2b trials with a favorable safety profile and no antibody-related lymphopenias.¹

The kappa-restriction approach adds a new mechanism to a multiple myeloma CAR-T pipeline that has grown increasingly crowded around BCMA-directed constructs; BioPharm International^© has covered how late-stage BCMA-targeted CAR-T and bispecific antibody candidates continue advancing toward earlier lines of treatment in relapsed/refractory disease.² This narrower, light-chain-specific targeting strategy is distinct from BCMA-directed approaches, which recognize an antigen expressed regardless of light-chain restriction — a difference that, if the safety benefit holds up in later-stage trials, could offer a more selective option for the kappa-restricted patient subset.

"This therapy is designed to provide a more targeted approach that could reduce impacts on the patient's immune system, compared with existing CAR T-cell therapies for multiple myeloma," said Professor Simon Harrison, director of the Centre of Excellence in Cellular Immunotherapy at Peter Mac. "If these potential benefits are confirmed in clinical trials, this could represent an important advance in the treatment of multiple myeloma. We welcome the treatment of the first patient in this trial and look forward to continuing to evaluate the safety and potential of this investigational therapy."¹

Why does immune-sparing selectivity matter for these patients?

Multiple myeloma is the world's second-most common blood cancer, with roughly 188,000 new cases diagnosed annually and about 543,000 people living with the disease globally; the disease remains incurable, and 42% of patients die within five years of diagnosis.¹ HaemaLogiX states that most currently approved BCMA-directed CAR-T therapies damage both cancerous and healthy immune cells, and that more than half of non-progressing patients face infection-related deaths rather than deaths from the cancer itself.¹

"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," said Rosanne Dunn, chief scientific officer at HaemaLogiX. "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. Seeing this work translate from the laboratory into human trials with positive safety data is a very important step forward for our immunotherapy programs."¹

What's next?

The KOALA dose-escalation trial will continue treating additional patients at escalating dose levels to assess safety and preliminary efficacy.¹ The KMCAR T-cells are manufactured by Cell Therapies Pty Ltd, a TGA-licensed GMP facility partnered with Peter Mac.¹ The trial is registered on ClinicalTrials.gov (NCT07541391).¹

References

1. HaemaLogiX announces major milestone with first patient successfully dosed with KMCAR T-Cell. News release. HaemaLogiX Ltd; August 26, 2026. Accessed August 26, 2026.
2. Schoenthaler E. Late-stage CAR-T, bispecific therapies drive transformation in the multiple myeloma pipeline. BioPharm International. Published May 27, 2026. Accessed August 26, 2026.