FDA Clears Kelonia Therapeutics’ IND for KLN-1010, Enabling First U.S. Multi-Center Trial of In Vivo Anti-BCMA CAR-T Therapy

BOSTON, Mass. — January 7, 2026— Kelonia Therapeutics, Inc., a clinical-stage biotechnology company focused on in vivo gene delivery, announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for KLN-1010 for the treatment of patients with relapsed and refractory multiple myeloma, marking the program’s second regulatory clearance and enabling its first multi-center clinical trial in the United States.

KLN-1010 is an investigational in vivo gene therapy designed to generate anti-BCMA CAR-T cells directly within patients following a single infusion, without the need for preparative chemotherapy or personalized CAR-T cell manufacturing. The FDA’s IND clearance allows Kelonia to expand its ongoing Phase 1 inMMyCAR™ clinical trial, which is currently enrolling patients in Australia, to multiple clinical sites across the U.S.

Initial safety and efficacy data from the first patients treated in the Phase 1 study were previously reported, demonstrating minimal residual disease (MRD)-negative responses at one month, with durability extending to three months in patients with the longest follow-up. The trial is designed to evaluate safety, tolerability, pharmacology, and preliminary efficacy of KLN-1010, while establishing a recommended Phase 2 dose.

The expansion into the U.S. represents a key step forward for in vivo CAR-T therapy, a rapidly emerging approach aimed at improving accessibility and scalability compared with traditional ex vivo CAR-T treatments for multiple myeloma.