A clinical trial in Australia that’s testing the genetic therapy KLN-1010 in people with hard-to-treat multiple myeloma has won regulatory approval to add new study sites in the U.S.
The Phase 1 study, dubbed inMMyCAR (NCT07075185), will soon start enrolling patients in the U.S. It will be recruiting 40 adults with multiple myeloma that is relapsed or refractory, meaning the disease has failed to respond to previous treatments or has come back after initially responding.
To be eligible for the study, patients must have had at least three prior lines of treatment, involving an immunomodulatory medication, a proteasome inhibitor, and an anti-CD38 antibody. All participants in the study will receive a single infusion of KLN-1010, with the main goal of evaluating safety outcomes for as long as 15 years of follow-up.
The use of KLN-1010, being developed by Kelonia Therapeutics, which is sponsoring the ongoing trial, does not require patients to first undergo chemotherapy before treatment.
The trial launched last year and is currently recruiting participants at three sites in Australia.
Now, Kelonia announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug application (IND) that, in part, gives the company a green light to expand the study to sites in the U.S.
“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,” Kevin Friedman, PhD, founder and CEO of Kelonia, said in a company press release.
KLN-1010 designed to work inside patients’ bodies
CAR T-cell therapies work by taking T-cells — a type of immune cell that can kill cancer cells — and equipping them with a molecular weapon called a chimeric antigen receptor (CAR) that directs them to attack a specific molecular target.
Several CAR T-cell therapies are approved to treat myeloma in some patients, but all available medicines in this class are ex vivo therapies. That means that T-cells are collected from a patient, taken to a lab to engineer them, then infused back into the patient, usually after a dose of chemotherapy and/or radiation to eradicate existing immune cells and make way for the modified ones.
KLN-1010 is a so-called in vivo CAR T-cell therapy. Essentially, it is a gene therapy designed to modify T-cells within a patient’s body so that they will express a CAR, eliminating the need for pretreatment chemotherapy and the time-consuming process needed to collect cells, take them to a lab, and transfuse them back into the patient. The therapy uses a CAR-targeting BCMA, a protein targeted by multiple ex vivo CAR T-cell therapies approved for myeloma.
Early trial results show no cancer for 4 participants
Friedman called the FDA’s recent IND clearance “an important milestone for KLN-1010 and for the broader field of in vivo CAR-T therapy.”
According to Friedman, the first four participants treated in the ongoing Phase 1 study were all minimum residual disease (MRD)-negative at one month after treatment, essentially meaning they had no detectable cancer cells in their bodies.
inMMyCAR is an dose-escalation clinical trial that’s aiming to assess the safety, tolerability, and preliminary effectiveness of a single dose of KLN-1010. It’s open label, meaning both researchers and participants know the medication being given.
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