FDA clears IND for Kelonia in vivo CAR-T in multiple myeloma

The U.S. FDA has cleared Kelonia Therapeutics’ Investigational New Drug (IND) application for KLN-101, an in vivo CAR-T therapy, for the treatment of patients with relapsed and refractory multiple myeloma. 

THe U.S. IND represents the second regulatory clearance for the company's lead candidate and enables the first multi-center clinical trial in the U.S. for an anti-BCMA in vivo CAR-T program.

KLN-1010 is a novel in vivo gene therapy designed to generate anti-BCMA CAR-T cells directly within patients following a single infusion, without the requirement of preparative chemotherapy or bespoke CAR-T cell manufacturing. FDA clearance of the IND enables Kelonia to expand its ongoing inMMyCAR phase 1 clinical trial, currently enrolling patients in Australia, to multiple clinical sites across the U.S. 

“Last month, we presented initial safety and efficacy data from the first four patients treated in our phase 1 study, all of whom achieved MRD-negative responses at one month, with durability extending through three months in the patients with the longest follow-up. The FDA’s clearance allows us to accelerate enrollment across multiple geographies and brings us a meaningful step closer to our goal of democratizing CAR-T therapies for patients with multiple myeloma,” said Kevin Friedman, Ph.D., CEO and founder of Kelonia.