HaemaLogiX doses first patient in KMCAR T-cell multiple myeloma trial
New CapabilitiesA CAR-T therapy designed to kill only cancerous plasma cells, sparing the healthy immune cells other treatments destroy
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Overview
Updated YesterdayHaemaLogiX dosed the first patient in its Phase 1 KOALA trial on August 26, and the infusion was well tolerated with no serious adverse events. A second patient is enrolled and set to receive a higher dose at Melbourne's Peter MacCallum Cancer Centre.
KMCAR is a CAR-T therapy that targets the Kappa Myeloma Antigen, a receptor found only on malignant kappa-type myeloma cells. Approved CAR-T therapies for myeloma target BCMA, which also appears on healthy plasma cells, so they deplete the patient's normal antibody-producing cells along with the cancer. KMCAR is engineered to leave healthy immune cells intact.
Why it matters
If KMCAR works, myeloma patients could get a therapy that kills cancer cells without wiping out the healthy immune system other CAR-Ts destroy.
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Timeline
March 2026 August 2026
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First patient dosed with KMCAR
Latest ClinicalFirst patient safely treated; infusion well tolerated with no serious adverse events. Second patient enrolled for a higher dose level.
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KOALA trial opens to enrollment
MilestoneTrial activated at Peter MacCallum Cancer Centre after TGA and ethics approval, moving KMCAR from preclinical development into clinical evaluation.
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TGA grants first-ever Australian CAR-T approval
RegulatoryAustralia's Therapeutic Goods Administration authorized the Phase 1 KOALA trial, the first first-in-human CAR-T therapy approved in the country.
Historical Context
2 moments from history that rhyme with this story — and how they unfolded.
Kymriah (tisagenlecleucel) approval (2017)
The U.S. Food and Drug Administration approved the first CAR-T therapy, Novartis's Kymriah, for pediatric acute lymphoblastic leukemia. It marked the first gene therapy approved in the United States, reprogramming a patient's own T cells to attack cancer.
Showed durable remissions in patients who had exhausted standard options, establishing CAR-T as a curative-intent therapy for blood cancers.
Sparked a wave of CAR-T development targeting other blood cancers, including multiple myeloma, and set the regulatory template for the field.
Kymriah proved CAR-T can work in humans; KMCAR is the next step in refining that approach to spare healthy cells.
Abecma (idecabtagene vicleucel) approval (2021)
Bristol Myers Squibb's Abecma became the first BCMA-targeted CAR-T therapy approved for multiple myeloma, after a trial showed responses in heavily pre-treated patients. BCMA is expressed on plasma cells, including healthy ones that produce antibodies.
Gave myeloma patients a powerful new option but caused B-cell aplasia and immune suppression as the healthy plasma cells were wiped out alongside the cancer.
Established BCMA as the dominant CAR-T target for myeloma, while highlighting the toxicity cost of targeting a receptor shared with healthy cells.
KMCAR is designed as a direct contrast: it targets KMA instead of BCMA, aiming for the tumor-killing benefit without the healthy-cell damage.
