Research & Development

Carthera® is developing proprietary technologies as a platform to treat various severe brain diseases

RESEARCH & DEVELOPMENT Clinical Pipeline

Our goal is to offer easy, well integrated and cost-effective treatments to both patients and clinicians.

Carthera’s priority is to develop therapeutic approaches that will benefit patients with high unmet needs. With our partnered institutions, we are addressing neuro-oncological indications with adult and pediatric glioblastoma and brain metastases trials, as well as neuro-degenerative indications such as Alzheimer’s Disease.

RESEARCH AND DEVELOPMENT Our Pipeline

Place your mouse over each trial to discover more information

Program	Indication	Pre-clinical	Phase 1	Phase 2	Phase 3	Marketed
SONOBIRD SC9-GBM-03 Patients: 560 Protocol: Multicenter, randomized Phase 3 clinical trial of recurrent glioblastoma patients eligible for surgery and then treated with either standard therapy (CCNU/TMZ) or with the SonoCloud® implantable medical device combined with carboplatin. Investigator-Sponsor: Carthera® Country: France, USA, Belgium, Netherlands, Switzerland, Austria, Germany, Spain, Italy NCT05902169 Details SC9-GBM-03 Patients: 560 Protocol: Multicenter, randomized Phase 3 clinical trial of recurrent glioblastoma patients eligible for surgery and then treated with either standard therapy (CCNU/TMZ) or with the SonoCloud® implantable medical device combined with carboplatin. Investigator-Sponsor: Carthera® Country: France, USA, Belgium, Netherlands, Switzerland, Austria, Germany, Spain, Italy NCT05902169 Details	Recurrent Glioblastoma
SC9-ABX SC9-ABX Patients: 57 Protocol: Phase 1/2 clinical trial of ultrasound barrier opening using the SonoCloud® implantable medical device and albumin-bound paclitaxel treatment combined with carboplatin in patients with recurrent glioblastoma. Investigator-Sponsor: Northwestern University Country: USA NCT04528680 Details SC9-ABX Patients: 57 Protocol: Phase 1/2 clinical trial of ultrasound barrier opening using the SonoCloud® implantable medical device and albumin-bound paclitaxel treatment combined with carboplatin in patients with recurrent glioblastoma. Investigator-Sponsor: Northwestern University Country: USA NCT04528680 Details	Recurrent Glioblastoma
SC9-IMMUNO SC9-IMMUNO Patients: 25 Protocol: Phase 2a clinical trial of of immune modulation in combination with ultrasound-mediated blood brain barrier opening using the SonoCloud® implantable medical device in patients with newly diagnosed glioblastoma. Investigator-Sponsor: Northwestern University Country: USA NCT05864534 Details SC9-IMMUNO Patients: 25 Protocol: Phase 2a clinical trial of of immune modulation in combination with ultrasound-mediated blood brain barrier opening using the SonoCloud® implantable medical device in patients with newly diagnosed glioblastoma. Investigator-Sponsor: Northwestern University Country: USA NCT05864534 Details	Newly Diagnosed Glioblastoma
SONOFIRST SONOFIRST Patients: 66 Protocol: Multisite open-label randomized phase 2 clinical trial in newly diagnosed glioblastoma treated by concurrent temoradiation and adjuvant temozolomide +/- ultrasound-induced blood brain barrier opening. Investigator-Sponsor: AP-HP Country: Belgium, France, Switzerland NCT04614493 Details https://sonofirst-trial.eu/en/ SONOFIRST Patients: 66 Protocol: Multisite open-label randomized phase 2 clinical trial in newly diagnosed glioblastoma treated by concurrent temoradiation and adjuvant temozolomide +/- ultrasound-induced blood brain barrier opening. Investigator-Sponsor: AP-HP Country: Belgium, France, Switzerland NCT04614493 Details https://sonofirst-trial.eu/en/	Newly Diagnosed Glioblastoma
SONOKID SONOKID Patients : 24 Protocole : Phase 1 clinical trial evaluating the tolerability of repeated opening of the blood-brain barrier by low-intensity pulsed ultrasound with the SonoCloud® implantable medical device prior to carboplatin chemotherapy in the treatment of recurrent primary supratentorial malignant brain tumors in children. Promoteur : AP-HP Pays : France NCT05293197 Details SONOKID Patients : 24 Protocole : Phase 1 clinical trial evaluating the tolerability of repeated opening of the blood-brain barrier by low-intensity pulsed ultrasound with the SonoCloud® implantable medical device prior to carboplatin chemotherapy in the treatment of recurrent primary supratentorial malignant brain tumors in children. Promoteur : AP-HP Pays : France NCT05293197 Details	Reccurent malignant pediatric brain tumors
SONIMEL SONIMEL Patients: 21 Protocol: Safety and efficacy of Blood Brain Barrier opening with the SonoCloud® implantable medical device combined with Nivolumab used alone or an association with Ipilimumab in brain metastases from patients with malignant melanoma. Investigator-Sponsor: AP-HP Country: France NCT04021420 Details SONIMEL Patients: 21 Protocol: Safety and efficacy of Blood Brain Barrier opening with the SonoCloud® implantable medical device combined with Nivolumab used alone or an association with Ipilimumab in brain metastases from patients with malignant melanoma. Investigator-Sponsor: AP-HP Country: France NCT04021420 Details	Brain metastases
BOREAL BOREAL Patients: 10 Protocol: Phase 1/2 monocentric clinical trial evaluating the safety and benefit of transient opening of the blood-brain barrier by low-intensity pulsed ultrasound with the SonoCloud® implantable medical device in patients with mild Alzheimer’s disease (MMSE 20-26). Investigator-Sponsor : APHP Country: France NCT03119961 Details BOREAL Patients: 10 Protocol: Phase 1/2 monocentric clinical trial evaluating the safety and benefit of transient opening of the blood-brain barrier by low-intensity pulsed ultrasound with the SonoCloud® implantable medical device in patients with mild Alzheimer’s disease (MMSE 20-26). Investigator-Sponsor : APHP Country: France NCT03119961 Details	Alzheimer’s Disease

Complete

Active

Research & Development Non-clinical Pipeline

Extensive research ongoing with world-renowned laboratories.

Since 2010, a large series of pre-clinical studies have been conducted by Carthera® in collaboration with world-renowned research laboratories. Today, extensive translational research is being conducted in parallel with the SonoCloud® clinical development.

Non-clinical programs, mainly focused on combining the US-BBB opening by SonoCloud® with new cytotoxic agents and/or immunotherapy approaches (e.g. adoptive cellular therapy, immune checkpoint blockade), are presently ongoing with prestigious research centers.

There is a unique opportunity to ascertain if US-BBB opening, by providing an actionable target in the brain tumor, will work in synergy with ICIs

Dr. Amy Heimberger

Professor of Neurological Surgery, Northwestern University, Chicago

RESEARCH & DEVELOPMENT Proprietary platform