The United States Food and Drug Administration cleared the investigational new drug application for KLN-1010, an in vivo BCMA-targeted CAR-T cell therapy, for patients with relapsed or refractory multiple myeloma.
KLN-1010 generates CAR-T cells directly in patients after a single infusion without preparative chemotherapy or ex vivo manufacturing. The clearance enables expansion of the ongoing phase 1 inMMyCAR trial from Australia to multiple sites in the United States. Initial data from the first four patients showed all achieved MRD-negative responses at one month, with durability through three months in the longest-followed cases, according to a press release by Kelonia Therapeutics, a clinical-stage biotechnology company.
“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, PhD, CEO and founder of Kelonia Therapeutics.
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