BOSTON – Kelonia Therapeutics, Inc. has dosed the first patient in its Phase 1 inMMyCAR study, marking the start of clinical testing for KLN-1010, a novel in vivo gene therapy that generates anti-BCMA CAR-T cells in patients with relapsed and refractory multiple myeloma.
Unlike traditional CAR-T treatments, KLN-1010 is administered directly to patients without the need for apheresis, ex vivo manufacturing, or lymphodepletion. The therapy represents the first anti-BCMA in vivo CAR-T program to be studied in a multi-center clinical trial.
“KLN-1010 offers hope to multiple myeloma patients who can’t access today’s CAR-T cell therapies,” said Kevin Friedman, Ph.D., chief executive officer and founder of Kelonia. “This first-in-human dosing marks a major milestone toward a future where CAR-T benefits can be delivered without preparative chemotherapy or bespoke manufacturing delays, and at virtually any hospital around the world. Beginning our Phase 1 inMMyCAR study is not only pivotal for patients, but for the entire field. It’s the starting point for transforming CAR-T cell therapies with our in vivo Gene Placement System (iGPS®) technology.”
Professor Simon Harrison, MBBS, MRCP(UK), FRCPath(UK), FRACP, Ph.D., director of the Centre of Excellence in Cellular Immunotherapy at the Peter MacCallum Cancer Centre in Melbourne and lead investigator of the inMMyCAR study, noted the potential impact for patients. “Multiple myeloma can be a challenging disease to treat as most patients experience relapse after initial treatment, and many become resistant to currently available therapies. In vivo CAR-T cell therapies would be transformative for these patients, providing rapid access to potentially life-saving treatments. We’re at a pivotal moment, in which we’re taking important steps to make such therapies a reality in Australia through highly novel clinical trials, and I’m proud to play a role in ushering in these innovative therapies.”
The trial is a multi-center, open-label, dose-escalation study evaluating the safety and preliminary efficacy of a single dose of KLN-1010. The first patient was treated at Royal Prince Alfred Hospital in Sydney, Australia, by inMMyCAR investigator Professor Joy Ho, MB.BS. (Hons), D.Phil (Oxon), FRACP, FRCPA, FFSc (RCPA).
“Dosing the first patient in the inMMyCAR Phase 1 study is a tremendous milestone and marks significant advancement towards bringing KLN-1010 to patients who need it most,” said Ho. “I and my team are proud to have achieved this proficiently. As an in vivo CAR-T cell therapeutic candidate, KLN-1010 has the potential to deliver the full promise of CAR-T cell therapies without the complex manufacturing requirements, lengthy production timelines and toxic lymphodepleting chemotherapy that ex vivo CAR-T cell therapies require. We believe it has the potential to revolutionize CAR-T therapy in myeloma.”
