Australia’s TGA grants CTA for first-in-human KMCAR T-cell therapy for kappa-restricted RRMM

On March 17, 2026, Australia’s Therapeutic Goods Administration (TGA) granted Clinical Trial Approval (CTA) for KMCAR T-cell, a novel autologous Kappa Myeloma Antigen (KMA)-directed chimeric antigen receptor (CAR) T-cell therapy for the treatment of kappa-restricted relapsed/refractory multiple myeloma (RRMM). 

The KOALA study is a phase I dose-escalation study and represents the first-in-human clinical evaluation of KMCAR in patients with kappa-restricted RRMM. KMA is expressed on the surface of malignant plasma cells but has not been reported on normal plasma cells. In preclinical models, KMCAR demonstrated specific and durable KMA-positive tumor cell killing compared with a negative control.