Experimental CAR T-cell therapy may offer safer path for myeloma care

A new CAR T-cell therapy designed to target multiple myeloma while sparing healthy immune cells has been given to its first patient in a Phase 1 clinical trial.

Because the initial dose of KMCAR, Haemalogix’s experimental therapy, appeared safe and well tolerated, a second patient has been enrolled and is scheduled to receive a higher dose.

The dose-escalating trial, called KOALA (NCT07541391), is assessing KMCAR’s safety and effectiveness in up to 12 adults with relapsed and refractory multiple myeloma, when the cancer has returned or responds poorly to treatment. Recruitment may still be ongoing at the Peter MacCallum Cancer Centre in Melbourne, Australia.

“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,” Rosanne Dunn, PhD, chief scientific officer at Haemalogix, said in a company press release.

Multiple myeloma is a type of blood cancer that begins in plasma cells, immune cells that normally produce antibodies to help the body fight infections. In multiple myeloma, cancerous plasma cells — called myeloma cells — start to grow out of control in the bone marrow, where blood cells are produced, causing symptoms.

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Preserving healthy immune cells

Although treatment for multiple myeloma has improved, many patients still experience relapse or become refractory, when the cancer no longer responds to treatment.

CAR T-cell therapy is being used increasingly for relapsed and refractory multiple myeloma, as well as for patients in earlier stages of the disease.

Like other CAR T-cell therapies, KMCAR involves collecting a patient’s own T-cells and modifying them to carry lab-made proteins called chimeric antigen receptors (CARs). These modified cells are then infused back into the bloodstream to seek out and destroy cancer cells.

KMCAR specifically targets the kappa myeloma antigen (KMA), a protein found on kappa-type myeloma cells — those producing high levels of abnormal antibodies containing what are known as kappa light chains — rather than healthy immune cells.

This allows the one-time therapy to target myeloma cells while preserving healthy immune function, an important distinction from some other CAR T-cell therapies. Destroying those healthy immune cells can weaken the immune response.

“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,” Dunn said.

KMCAR could offer an alternative to therapies targeting BCMA, a protein highly present in myeloma cells but also found on some normal antibody-producing immune cells.

“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 Simon Harrison, PhD, the director of the Peter MacCallum’s Centre of Excellence in Cellular Immunotherapy. “If these potential benefits are confirmed in clinical trials, this could represent an important advance in the treatment of multiple myeloma.”

The KOALA trial is enrolling up to 12 adults with a diagnosis of kappa-restricted multiple myeloma who have received at least two previous lines of treatment. Participants receive a single infusion of KMCAR, with doses increasing gradually in small groups to find a dose that is safe and effective.

The study’s main goals are to assess KMCAR’s manufacturing feasibility and safety about a month after treatment, while secondary goals include tracking several efficacy measures up to one year after treatment. The trial is expected to end in 2030.