Bemdaneprocel for motor symptoms in adults with Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The BRT-DA01-301 Phase 3 trial is a multicenter, randomized, sham surgery-controlled, double-blind study enrolling about 102 adults with Parkinson's disease who meet specific levodopa- and dopamine-responsiveness criteria. Participants are randomized 2:1 to receive either bemdaneprocel (with an immunosuppression regimen) or sham surgery with placebo-equivalent procedures to maintain blinding. The primary outcome focuses on change in motor symptoms, and secondary outcomes include motor function, quality of life, non-motor symptoms, disease severity, and use of PD medications or therapies. Participants are followed for at least 18 months in the double-blind period and may be followed up to five years if they receive bemdaneprocel.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of clinically established PD as defined by the International Parkinson and Movement Disorders Society
* Individual of any sex ≥45 to ≤75 years of age at informed consent
* Robust and clear response to DA therapy as defined by MDS-UPDRS Part III
* ≥4 and \<12 years from time of PD diagnosis at informed consent
* Must demonstrate responsiveness to levodopa therapy
* Receiving medical therapy for the treatment of PD symptoms
* ≥2.5 hours of daily OFF-time
* Vaccinated per current national guidelines or local practice for patients with altered immunocompetence

Exclusion Criteria:

* PD presenting with recurrent falls
* Diagnosis of primary mitochondrial disorder, epilepsy, stroke, multiple sclerosis, or clinical features suggestive of a neurodegenerative disease other than PD, including multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, or Lewy body dementia
* Any current or relevant previous history of serious, severe, or unstable physical, neurological, or psychiatric illness that may interfere with study participation, participant's safety, or assessment of endpoints per investigator's judgment
* History of gene therapy or cell therapy for a neurological or intercerebral condition
* Prior treatment with intrajejunal or subcutaneous infusion therapies for PD
* Prior surgical or radiation therapy to the brain, including deep brain stimulation (DBS) and lesion therapy, or prior history of intradural spinal cord surgery
* Contraindication to surgery, general anesthesia, cell therapy, immunosuppression, or other required drugs, or anything that prevents use of PET or MRI
* Any history or evidence of infection with HBV or HIV; any active infection with HCV, CMV, syphilis, or latent tuberculosis; and any condition that, in the opinion of the investigator could put the participant at significant risk from immunosuppression or impact the participant's ability to perform study assessments. Exceptions: Treated and resolved TB, syphilis and/or HCV are not exclusionary
* Current or previously active malignant disease within the past 5 years
* Chronic immunosuppressive therapy
* Receipt of another investigational therapy within 5 half-lives of the active treatment
* Pregnancy or breastfeeding
* Unable to comply with study requirements for any reason

Where it's running

• Mayo Clinic Scottsdale - Neurology
  Scottsdale, Arizona, United States Recruiting
• Banner Sun Health Research Institute
  Sun City, Arizona, United States Recruiting
• University of Arkansas for Medical Sciences
  Little Rock, Arkansas, United States Recruiting
• UCLA NeuroTranslational Research Center
  Los Angeles, California, United States Recruiting
• UCI Medical Center - Neurology
  Orange, California, United States Recruiting
• Stanford Neuroscience Health Center
  Palo Alto, California, United States Recruiting

Study contacts

• Study coordinator: Patient Engagement
• Email: clinicaltrials@bluerocktx.com
• Phone: 1-877-380-3967

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.