PARIS — Carthera, a French medical technology firm, has enrolled the first 100 patients in its pivotal SONOBIRD clinical trial, marking a major milestone in what is set to be the largest study of its kind for recurrent glioblastoma treatment using ultrasound-based blood-brain barrier (BBB) opening.
The trial, spanning nearly 40 active sites across Europe and the United States, is designed to evaluate Carthera’s SonoCloud® device, an implantable ultrasound technology developed to temporarily open the BBB and enhance drug delivery to the brain. Carthera plans to enroll a total of 560 patients, making this the world’s first randomized, multicenter pivotal trial testing ultrasound BBB opening before chemotherapy in glioblastoma patients.
The study (NCT05902169) compares the use of SonoCloud combined with the chemotherapy drug carboplatin to standard-of-care therapies for patients experiencing a first recurrence of glioblastoma, an aggressive and often treatment-resistant brain cancer.
“It has been a privilege to offer this trial to patients with recurrent glioblastoma,” said Dr. Brian Gill, assistant professor of neurosurgery at Columbia University Irving Medical Center in New York. “The underlying concept is highly promising, device implantation has proceeded smoothly, and patient interest has been strong.”
Neuro-oncologist Dr. Marjolein Geurts from Erasmus Medical Center Cancer Institute in Rotterdam added, “We desperately need new treatments for recurrent glioblastoma. SonoCloud has the potential to transform how we deliver high-dose therapeutics directly to the brain.”
To date, more than 550 SonoCloud treatments have been performed worldwide, reinforcing Carthera’s position at the forefront of ultrasound-mediated BBB opening and drawing growing interest in the technology as a new approach for treating glioblastoma.
“Our recruitment progress reflects the dedication of clinical sites and the neuro-oncology community in advancing innovative therapies,” said Carole Desseaux, Carthera’s chief clinical officer. “We are grateful for the enthusiasm and commitment of the patients and clinicians involved.”
“This milestone brings us closer to introducing SonoCloud to a patient population in urgent need of improved treatment options,” added Frederic Sottilini, CEO of Carthera. “With both breakthrough device and orphan drug designations, we remain committed to transforming glioblastoma care and securing market access for this groundbreaking technology.”
The SONOBIRD trial, which began in February 2024, aims to complete enrollment within two years, with interim clinical data expected soon. The trial’s results could pave the way for regulatory approval of the SonoCloud device in both the U.S. and European markets.
