# HaemaLogiX Announces Major Milestone with First Patient Successfully Dosed with KMCAR™ T-Cell

- Link: https://www.thailand-business-news.com/pr-news/haemalogix-announces-major-milestone-with-first-patient-successfully-dosed-with-kmcar-t-cell
- Published: 2026-08-26T07:00:00+07:00
- Author: PR Newswire

**KEY POINTS**

 ◦ First patient safely dosed in Phase 1 KOALA trial evaluating KMCAR™ T-cell therapy
   in patients with relapsed/refractory kappa-restricted multiple myeloma 
 ◦ Patient was monitored after initial dose to assess response and side-effects,
   with the treatment seen as well tolerated, and second patient to be treated imminently
 ◦ The study is the first in-human trial for the novel KMCAR™ T-cell immunotherapy,
   which targets the Kappa Myeloma Antigen (KMA), a tumour-specific receptor found
   only on malignant plasma cells
 ◦ Unlike other therapies currently available that can deplete both cancerous and
   healthy immune cells, KMCAR™ T-cell therapy selectively recognises and eliminates
   KMA myeloma cells while preserving healthy immune cells that are essential for
   immune defence.

SYDNEY, Aug. 26, 2026 /PRNewswire/ — HaemaLogiX Ltd is pleased to announce another
milestone in its ongoing Phase 1 KOALA trial, with the first patient having been
safely treated with KMCAR™ T-cell therapy. Following an initial infusion, the patient
demonstrated that the treatment was well-tolerated, with no serious adverse events.
A second patient on the trial has now been enrolled and is set to be treated at 
a higher dose level.

The KOALA study, being conducted at the Peter MacCallum Cancer Centre, is a dose-
escalation trial, assessing the safety and preliminary efficacy of HaemaLogiX’s 
proprietary KMCAR™ T‑cell technology (PMCC-COE-KMA). The study is being conducted
in patients with multiple myeloma who are no longer responding to standard treatment
options, and who are not eligible for other CAR-T therapies. 

Multiple myeloma is the world’s second-most common blood cancer, with around 188,000
new cases each year^([1]) and roughly 543,000 people living with the disease^([2]).
It remains incurable, and 42% of patients die within five years of diagnosis^([3]).
Most effective treatments only delay the progression of the cancer, but in doing
so, damage or destroy the immune system of the patient. Most currently approved 
BCMA-directed CAR-T therapies target both cancerous and healthy cells, leading to
weakening of the immune system and opportunistic infections. This can ultimately
lead to more than half of non-progressing patients facing infection-related deaths,
rather than deaths from the cancer itself.

By contrast, HaemaLogiX’s KMCAR™ T-cell therapy is designed to target the Kappa 
Myeloma Antigen (KMA) – a tumour-specific receptor found only on kappa-type myeloma
cells, and absent from healthy immune cells. KMCAR™ T-cells are the patient’s own
immune cells that are redirected to destroy the cancer-causing cells, while sparing
normal immune function and other tissues. This unique specificity is what differentiates
the treatment from anything currently available for multiple myeloma patients today.

Delivery of the therapy involves the harvesting and genetic modification of T cells
from a patient’s own blood, which are engineered to create KMCAR™ T-cells, that 
are then infused back into the patient. These cells recognise and destroy cancerous
plasma cells that express KMA, while sparing healthy immune cells.

KMCAR™ T-cell therapy is derived from HaemaLogiX’s proprietary KappaMab™ antibody
technology, which has been validated across Phase 1, 2a and 2b clinical trials. 
KappaMab™ has also demonstrated a favourable safety profile with no antibody related
lymphopenias and durable patient responses.

Professor Simon Harrison, Director of the Centre of Excellence in Cellular Immunotherapy
at Peter Mac, said: _"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. 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."_

Dr Rosanne Dunn, Chief Scientific Officer at HaemaLogiX, said: _"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._ _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. Our thanks to the first patient for joining the study
and to our colleagues at Peter MacCallum Centre of Excellence in Cellular Immunotherapy
for their commitment to progressing this important study."_

**About Multiple Myeloma** 

Multiple myeloma is a blood cancer arising from plasma cells that proliferate 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
at risk of serious 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 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
Practice (GMP) facility. 

The KOALA trial is registered on ClinicalTrials.gov (Identifier: NCT07541391): [https://clinicaltrials.gov/study/NCT07541391](https://clinicaltrials.gov/study/NCT07541391).

**-ENDS-** 

**About Peter MacCallum Cancer Centre** 

Peter MacCallum Cancer Centre is a world leading cancer research, education and 
treatment centre and Australia’s only public health service dedicated to caring 
for people affected by cancer. The Centre of Excellence in Cellular Immunotherapy
at Peter Mac is at the forefront of developing and delivering CAR-T cell therapies
for Victorian patients. [www.petermac.org](http://www.petermac.org/)  

**About** **HaemaLogiX** **Ltd** 

Founded in 2014, HaemaLogiX Ltd is a clinical-stage biotechnology company developing
novel immunotherapies for patients with blood cancers and B-cell diseases. HaemaLogiX
is the first and only company developing antibody and CAR-T therapies targeting 
the novel Kappa Myeloma Antigen (KMA) and Lambda Myeloma Antigen (LMA). HaemaLogiX
was awarded "Most Promising CAR-T Pipeline in APAC" at the Asia Pacific CGT Excellence
Awards 2025. [www.haemalogix.com](http://www.haemalogix.com/)  

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^([1]) Mafra A, Laversanne M, Marcos-Gragera R et al. The global multiple myeloma incidence and mortality burden in 2022 and predictions for 2045. J Natl Cancer Inst. 2025 May 1;117(5):907-914.

^([2]) Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin., 2024; 74(3): 229-263; Hou Q, Li X, Ma H, Fu D, Liao A. A systematic epidemiological trends analysis study in global burden of multiple myeloma and 29 years forecast. Sci Rep. 2025 Jan 16;15(1):2204.

^([3]) SEER Cancer Stat Facts: Multiple Myeloma 2022, [https://seer.cancer.gov/statfacts/html/](https://seer.cancer.gov/statfacts/html/mulmy.html)[mulmy.html](https://seer.cancer.gov/statfacts/html/mulmy.html).

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