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

Overview

Updated Aug 26

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

Patients dosed to date

First patient treated safely; a second is enrolled at a higher dose level.

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.

Voices

Curated perspectives — historical figures and your fellow readers.

Ever wondered what historical figures would say about today's headlines?

Organizations Involved

HaemaLogiX Ltd

Biotechnology company

Sponsor of the KOALA trial

Australian biotech developing CAR-T therapies for multiple myeloma.

Peter MacCallum Cancer Centre

Cancer research hospital

Trial site and lead sponsor

Melbourne-based cancer center conducting the KOALA Phase 1 trial.

Timeline

March 2026 August 2026

3 events Latest: August 26th, 2026 · 2 weeks ago

August 2026
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.
August 26th, 2026
May 2026
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.
May 19th, 2026
March 2026
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.
March 17th, 2026

Scenarios

KMCAR clears dose escalation, advances toward Phase 2

Likely Resolves by Q2 2027

Discussed by: HaemaLogiX corporate announcements and clinicaltrials.gov registration

Dose escalation completes without dose-limiting toxicities, and HaemaLogiX identifies a maximum tolerated dose. The company reports an efficacy signal from the 12-patient study and begins planning a Phase 2 trial. This is the default path for a therapy that showed clean preclinical killing of KMA-positive tumor cells.

Dose-limiting toxicity halts the KOALA trial

Possible Resolves by Q2 2027

Discussed by: Clinical trial safety protocols at Peter MacCallum

A patient at a higher dose level experiences a dose-limiting toxicity, triggering the protocol's stopping rules. The trial pauses while the safety data is reviewed, and HaemaLogiX may redesign the regimen or add a lower-dose cohort. This is the standard risk in any dose-escalation study.

KOALA completes with modest results and protocol revisions

Possible Resolves by Q3 2028

Discussed by: Phase 1 trial design constraints

The trial finishes with no dose-limiting toxicities but limited efficacy in the heavily pre-treated patient population. HaemaLogiX treats the data as proof of concept but adjusts the protocol, possibly testing combination therapy or earlier-line treatment before committing to Phase 2.

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.