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HaemaLogiX doses first patient in KMCAR T-cell multiple myeloma trial

HaemaLogiX doses first patient in KMCAR T-cell multiple myeloma trial

New Capabilities

A CAR-T therapy designed to kill only cancerous plasma cells, sparing the healthy immune cells other treatments destroy

Yesterday: First patient dosed with KMCAR

Overview

Updated Yesterday

HaemaLogiX 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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Key Indicators

1
Patients dosed to date
First patient treated safely; a second is enrolled at a higher dose level.
12
Estimated trial enrollment
Phase 1 dose-escalation study registered on clinicaltrials.gov as NCT07541391.
Phase 1
Trial phase
Dose-escalation study assessing safety and preliminary efficacy in relapsed or refractory patients.

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Organizations Involved

Timeline

March 2026 August 2026

3 events Latest: Yesterday
  1. First patient dosed with KMCAR

    Latest Clinical

    First patient safely treated; infusion well tolerated with no serious adverse events. Second patient enrolled for a higher dose level.

  2. KOALA trial opens to enrollment

    Milestone

    Trial activated at Peter MacCallum Cancer Centre after TGA and ethics approval, moving KMCAR from preclinical development into clinical evaluation.

  3. TGA grants first-ever Australian CAR-T approval

    Regulatory

    Australia'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.

August 2017

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.

Then

Showed durable remissions in patients who had exhausted standard options, establishing CAR-T as a curative-intent therapy for blood cancers.

Now

Sparked a wave of CAR-T development targeting other blood cancers, including multiple myeloma, and set the regulatory template for the field.

Why this matters now

Kymriah proved CAR-T can work in humans; KMCAR is the next step in refining that approach to spare healthy cells.

March 2021

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.

Then

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.

Now

Established BCMA as the dominant CAR-T target for myeloma, while highlighting the toxicity cost of targeting a receptor shared with healthy cells.

Why this matters now

KMCAR is designed as a direct contrast: it targets KMA instead of BCMA, aiming for the tumor-killing benefit without the healthy-cell damage.

Sources

(8)