A Phase I, First-in-human, Open-label, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BNT317 in Patients With Advanced Solid Tumors

Date Added
August 7th, 2025
PRO Number
Pro00143120
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Drug Studies
Summary

This study is for patients that have been diagnosed with advanced solid tumors. This study is testing an investigational drug called BNT317. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of this study is to evaluate the safety, tolerability, absorption of BNT317. BNT317 is administered via intravenous (IV) infusion. Participants can continue to receive this study drug until it no longer gives them benefit. Researchers will continue to follow-up with patients long-term.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@musc.edu

A Randomized, Multicenter, Phase III Trial of Tacrolimus/Methotrexate/Ruxolitinib versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation

Date Added
August 11th, 2025
PRO Number
Pro00146236
Researcher
Jonathan Alexander

List of Studies

Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This phase 3 study is recruiting patients who are at risk of graft-versus-host disease (GVHD) after a bone marrow transplant. This study will measure the safety and effectiveness of a prevention treatment combination called Tacrolimus/Methotrexate/Ruxolitinib compared to Standard of Care (SOC), Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil. Ruxolitinib (Rux) is an approved treatment for GVHD. This study is divided into two parts. The first part, called the run-in phase, will investigate the best dose of Ruxolitinib. The second part of the study will compare the SOC combination therapy with the investigational combination therapy (which will include Ruxolitinib). Participants will be randomly assigned to one of the two groups (like flipping a coin). The study will enroll up to 572 patients nationwide and 5 at MUSC. The participants can expect to be involved in the study for at least 24 months. The main risk is that medical treatments often cause side effects. The most common side effects expected from the investigational combination therapy are high cholesterol, increased liver enzymes, low platelet levels, and low red blood cell counts. There is no direct benefit for them in participating in this study.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@musc.edu

An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone in the Treatment of Pediatric Patients with Schizophrenia, Bipolar Disorder, or Autism Spectrum Disorder

Date Added
August 21st, 2025
PRO Number
Pro00140167
Researcher
Thomas Uhde

List of Studies


Keywords
Autism
Summary

Currently, there are no FDA-approved medications for the treatment of irritability associated with Autism Spectrum Disorder (ASD). This study is designed to look at the usefulness and safety of lumateperone (CAPLYTA) for the treatment of irritability associated with ASD among pediatric participants between the ages of 5 to 17 years. The study will last approximately 26 weeks and the participants will receive the study drug, lumateperone.

Institution
MUSC
Recruitment Contact
Jelissa Suarez
843-876-9262
suarezj@musc.edu

Prospective changes in patient-reported and objective functioning following reduction of cannabis use

Date Added
September 2nd, 2025
PRO Number
Pro00145652
Researcher
Rachel Tomko

List of Studies


Keywords
Mental Health, Psychiatry, Substance Use
Summary

Adults (ages 18+) who use cannabis and are interested in reducing their use will be enrolled in an 8-week treatment program. All participants will receive counseling (1 goals session with a therapist followed by 7 weekly computerized cognitive-behavioral therapy sessions). Detailed cannabis assessments (biological and self-report) will be conducted throughout treatment and at 1- and 4-months post-treatment completion. Daily electronic diaries will be administered via text message to record detailed logs of cannabis use quantity and frequency. Participants are also asked at different points throughout the study to wear a Fitbit to monitor their sleep.

Institution
MUSC
Recruitment Contact
Kevin Branson
843-792-0493
bransonk@musc.edu

Accelerated, Left Prefrontal Transcranial Magnetic Stimulation for Functional Seizures; An Open-Label Exploration of Feasibility, Tolerability, and Preliminary Efficacy

Date Added
September 2nd, 2025
PRO Number
Pro00144502
Researcher
Joseph Chasen

List of Studies

Keywords
Mental Health, Psychiatry
Summary

As growing research suggests noninvasive brain stimulation techniques have the potential to adjunct current treatments or treat Seizure-Type Functional Neurologic Disorder (FND-seiz), also known as Psychogenic Non-Epileptic Seizures (PNES), we aim to evaluate whether a form of accelerated intermittent theta burst transcranial magnetic stimulation (a-iTBS-rTMS), is a practical and well-tolerated treatment for people with this disorder. Transcranial Magnetic Stimulation or TMS uses magnetic pulses to stimulate a part of the brain involved in mood and thinking, the left dorsolateral prefrontal cortex, which has established benefits in disorders known to coincide in patients with FND-seiz, such as depression.

As an open-label, early feasibility study, enrolled participants will receive 6 to 10 treatment sessions each day over 3 to 5 days, with the goal of completing 30 total sessions. This approach was selected because similar protocols have already been shown to be safe and effective in other conditions, and the shortened treatment schedule in comparison to other protocols may make participation easier for people living with FND-seiz. The main goal of the study is to see how many participants can safely and comfortably complete at least 20 of the 30 TMS sessions.

The researchers will also evaluate changes in seizure frequency, quality of life, mood, post-traumatic stress symptoms, physical health, social functioning, and overall satisfaction with treatment. These outcomes will be measured before treatment and again four weeks afterward. The researchers also aim to explore whether people with overlapping conditions, such as depression or PTSD, respond differently to the treatment. Finally, given the overlap between epilepsy and FND-seiz, not all TMS providers are comfortable treating patients with FND-seiz when TMS is indicated for other conditions, thus the researchers aim to outline a protocol to ensure safety and increase TMS access for FND-seiz patients.

Institution
MUSC
Recruitment Contact
Joseph Chasen
(843) 637-1358
chasenj@musc.edu

TMS-iEEG Causal Mapping of Cognitive-Emotional Network Dynamics in Epilepsy

Date Added
September 2nd, 2025
PRO Number
Pro00146626
Researcher
Lisa McTeague

List of Studies


Keywords
Brain, Depression, Epilepsy, Mental Health, Psychiatry
Summary

Patients with drug-resistant epilepsy often experience problems with mood, thinking, or behavior that cannot be explained by seizure activity alone. This study will examine how cognitive and mood-related brain regions communicate in patients undergoing routine intracranial electroencephalogram (iEEG) seizure assessment in the Epilepsy Monitoring Unit at the Medical University of South Carolina (MUSC). While the clinical electrodes are in place, we will apply brief single magnetic pulses (single-pulse transcranial magnetic stimulation, or spTMS) to the scalp in specific brain regions and record the brain's electrical response through the existing electrodes; no additional surgery is required. We will compare the responses to stimulation of an emotionally and cognitively relevant region (left dorsolateral prefrontal cortex) with a contrast site (primary motor cortex). We will also investigate whether momentary brain rhythms and seizure-related electrical activity affect responses propagation through the brain. The findings may help identify measurable brain signaling patterns ("biomarkers") to understand how cognitive-emotional brain networks work in people with epilepsy and inform future personalized non-invasive brain stimulation methods for treating neurological and psychiatric disorders.

Institution
MUSC
Recruitment Contact
Corbin Ping
(843) 608-0329
pingc@musc.edu

Integrating corticospinal tract assessment via sTMS and taVNS-augmented CIMT in infants with hemiplegia

Date Added
September 2nd, 2025
PRO Number
Pro00146198
Researcher
Dorothea Jenkins

List of Studies


Keywords
Brain, Central Nervous System, Infant, Pediatrics, Physical Therapy, Rehabilitation Studies, Stroke Recovery
Summary

Newborns who are born premature or infants who suffer brain injury are at risk for motor problems. The common motor skills of reaching and grasping that infants have to learn can be weaker on one side of the body, depending on the site of the brain injury. These skills are routinely practiced with an occupational therapist once or twice a week, to help the infant strengthen these skills. A high intensity therapy program of constraint induced movement therapy (CIMT) may be available for the infant, but it takes from 40-120 hours total treatment time for most infants to improve their motor skills.
Transcutaneous auricular vagus nerve stimulation (taVNS) stimulates a branch of a major nerve by the ear, called the vagus nerve, that may help improve your child's ability to learn motor skills. CIMT involves placing a soft mitt constraint on the stronger arm and hand while encouraging your child to use the weaker arm and hand during intensive therapy sessions. By using both CIMT and the nerve stimulation together, we hope your child's movement skills will improve more than with therapy alone.
The purpose of this study is to evaluate the safety and effectiveness of taVNS to improve motor skills when paired with the minimal amount of CIMT and whether a measure of the strength of the brain circuit to the arm and hand muscles can tell us how well a child may respond to this therapy.

Institution
MUSC
Recruitment Contact
Dorothea Jenkins
843-792-2112
jenkd@musc.edu

Open Pilot Trial of an Integrated Intervention for PTSD/AUD Symptoms Following Recent Trauma

Date Added
September 2nd, 2025
PRO Number
Pro00146740
Researcher
Christine Hahn

List of Studies


Keywords
Women's Health
Summary

This study is for people who have experienced a traumatic event in the past one year and drink alcohol. The research involves completing a five week behavioral treatment for stress and alcohol use. Participants will complete surveys during visits. Participants may also be asked to complete a interview about their experiences.

Institution
MUSC
Recruitment Contact
Christine Hahn
8437923386
hahnc@musc.edu

Exploring Caregiving Choice in the Adult Cancer Population: A Multi-Method Study

Date Added
September 9th, 2025
PRO Number
Pro00145673
Researcher
Jennifer Huggins

List of Studies

Keywords
Cancer, Non-interventional
Summary

Using surveys researchers will assess caregiver choice, caregiver quality of life (CQOL), caregiver sleep, caregiver stress, and caregiver burden (CB). Some participants answering surveys (approximately 20), will be chosen by researchers to participate in an interview to gain a deeper understanding of the perspectives of individuals who assume caregiving responsibilities without a personal sense of choice.

Institution
MUSC
Recruitment Contact
Jennifer Huggins
854.429.2454
hugginje@musc.edu



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