At-home transcutaneous auricular neuromodulation (tAN) for women with postpartum depression: an open label trial

Date Added
March 3rd, 2026
PRO Number
Pro00149664
Researcher
Jeffrey Borckardt

List of Studies


Keywords
Anxiety, Depression, Women's Health
Summary

This is an open-label pilot study firstly assessing safety and feasibility of a form of ear stimulation called transcutaneous auricular neuromodulation, or tAN, in women with postpartum depression (PPD). Secondly, we will be assessing the impact of at-home tAN on mood, empathy, and physiological markers of sympathetic activity in women with PPD. Participants will learn how to self-administer ear stimulation treatments in the lab before starting the at-home study. Over the course of one week, participants will self-administer ear stimulation treatments three times a day. Each treatment will last up to 60 minutes (1 hour) and there will be a break of at least 30 minutes in between treatments. The study team will ask participants to complete a group of questionnaires at the beginning and end of the study, as well as undergo heart rate variability (HRV) assessments and provide salivary samples. There will also be a smaller number of questionnaires completed electronically at the midpoint of the study. The questionnaires will ask questions about mental health symptoms that subjects may or may not be experiencing, including questions about mood, anxiety, and feelings towards their newborn.

Institution
MUSC
Recruitment Contact
Nicole Cash
843-792-9502
cashni@musc.edu

A Phase 1, open-label, dose-escalation and dose-expansion study evaluating AO-252, a protein-protein interaction inhibitor of TACC3, in patients with advanced solid tumors with or without brain metastases

Date Added
February 24th, 2026
PRO Number
Pro00148001
Researcher
Brian Orr

List of Studies

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

This study is for patients that have been diagnosed with metastatic or locally advanced unresectable solid tumors with tumor protein 53 (TP53) mutation/loss with or without brain metastasis. This study is testing an investigational drug called AO-252. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of this study is to determine the maximum tolerated dose (MTD), the recommended phase II does (RP2D), and the safety profile of AO-252. The drug is given to participants orally. Participants can expect to be on this study for approximately 24 months, followed by a 12-month follow-up period.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Phase 1b Dose Expansion Study of NXC-201 for the Treatment of Patients with Relapsed or Refractory AL Amyloidosis

Date Added
February 11th, 2026
PRO Number
Pro00144745
Researcher
Kimberly Green

List of Studies

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

The purpose of this study is to test the safety of NXC-201 at different doses in participants with relapsed/refractory AL amyloidosis, and to confirm the best dose for further testing. In addition, the study will evaluate the effectiveness of NXC-201 in treating relapsed/refractory AL amyloidosis.

AL amyloidosis is a rare systemic disorder caused by an abnormality of plasma cells (a type of white blood cell that is part of the immune system) in the bone marrow. Misfolded proteins produced by these cells can build up in and around tissues, nerves and organs, gradually affecting their function. This can cause progressive and widespread organ damage.

NXC-201 is made using a person's own T Cells (immune system cells that protect the body from infections, cancer, and other possible harms). The T cells are collected then genetically modified (changes are made to the DNA or genes) outside of the body in a laboratory. A virus is used to introduce a gene that creates a protein (called a chimeric antigen receptor or CAR) on the surface of T cells. The virus then becomes inactive. The changes are designed to help the NXC-201 cells find and destroy plasma cells that have a protein on their surface called B-cell maturation antigen (BCMA). T-cell therapies like NXC-201 are called CAR T-cell therapies. After being reinjected, the CAR-T cells multiply and spread throughout the body.

NXC-201 is an investigational "treatment", which means it has not been approved by the US Food and Drug Administration (FDA) for the treatment of AL Amyloidosis or any other disease.

Calling the study drug a "treatment" in this consent form does not indicate that it will be effective in treating your AL Amyloidosis.

Before receiving NXC-201, participants will receive lymphodepleting chemotherapy (or lymphodepletion) with cyclophosphamide and fludarabine to briefly weaken (suppress) your immune system. The lymphodepletion will help prepare the body for receiving NXC-201. Cyclophosphamide and fludarabine are FDA-approved for use as lymphodepleting chemotherapy.

This study is sponsored by Nexcella, Inc., which is responsible for funding and organizing the study.

Institution
MUSC
Recruitment Contact
Thomas Hortman
8437929300
hortman@musc.edu

A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer

Date Added
January 27th, 2026
PRO Number
Pro00146193
Researcher
Abirami Sivapiragasam

List of Studies

Keywords
Cancer/Breast, Drug Studies, Women's Health
Summary

This study is for patients that have been diagnosed with breast cancer. The purpose of this research is to assess the safety and efficacy of sacituzumab tirumotecan (sac-TMT) in people with certain types of breast cancer who will have surgery to remove their breast cancer. This trial will compare two treatment plans that patients will receive before their surgery. One of these treatment plans will involve patients receiving Sac-TMT and pembrolizumab (pembro), followed by chemotherapy and pembro. Patients enrolled in the other treatment plan will receive chemotherapy and pembro. Patients will be given the drug intravenously (a needle in a vein). Patients may experience a decrease in white blood cells, platelets, and red blood cells (anemia). Patients are expected to remain in the study for a minimum of 30 months or longer. There will be a total of 12 patients locally enrolled.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Examining Return to Substance Use and Preferences for Substance Use Resources Among Postpartum Women

Date Added
January 22nd, 2026
PRO Number
Pro00148416
Researcher
Jordyn Tipsword

List of Studies

Keywords
Women's Health
Summary

This study is for women who have delivered a child in the past 18 months, have experienced one or more traumatic events during their lifetime, and use substances. First, the research involves completing brief screening questions over the phone to determine eligibility for the study. Second, eligible women will be invited to complete a 60- to 90-minute study visit comprised of an online survey and an interview about their opinions on postpartum substance use and potential future resources to help address substance use among postpartum women with trauma histories.

Institution
MUSC
Recruitment Contact
Jordyn Tipsword
8432847995
tipsword@musc.edu

Magnetic Cell Selection System for CD34+ Cells From HPC-Apheresis Used in Treatment of Acute Myeloid Leukemia

Date Added
January 20th, 2026
PRO Number
Pro00148616
Researcher
Alexander Coltoff

List of Studies

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

This is a clinical use of an FDA-approved Humanitarian Use Device (HUD) under a Humanitarian Device Exemption (HDE) called Miltenyi Biotec CliniMACS CD34. The intent is to treat patients with Myelodysplastic Syndrome (MDS) in a clinical setting, not to conduct research or gather data on safety or effectiveness. No data will be collected beyond what is required for standard clinical care. Device-related processing will occur at an NMDP Advanced Cell Therapy Lab Solutions facility, and the resulting cell product will be transported to MUSC Hollings Cancer Center for infusion. Eligible patients are in first complete remission and undergoing allogeneic stem cell transplant (SCT) from an HLA-identical matched related donor. Patients will be provided MUSC's standard treatment consent per institutional policies. The HUD will be stored, dispensed, and used at NMDP in accordance with standard operating procedures.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Randomized Phase II/III Study of Docetaxel and Ramucirumab with or Without Cemiplimab (REGN2810) for Participants Previously Treated with Platinum-based Chemotherapy and Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Non-Matched Sub-Study)

Date Added
January 15th, 2026
PRO Number
Pro00149083
Researcher
Christopher Rangel

List of Studies

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

This study is for patients who have non-small cell lung cancer that is stage IV or has returned after remission. The goal is to compare the usual treatment by itself to the usual treatment plus a drug called cemiplimab. "Investigational" means this drug combination has not been approved by the U.S. Food and Drug Administration (FDA). A computer will randomly assign patients to one of two groups. This process is called "randomization." Patients will be placed into a group by chance, like flipping a coin, and will have an equal chance of being in Group 1 or Group 2. The drug is given by infusion. Patients will keep getting treatment until the cancer gets worse. Each treatment cycle lasts 21 days. After the last cycle, patients will be followed for up to 3 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinicaltrials@musc.edu

A Phase II Study of Combined Amivantamab, Carboplatin and Paclitaxel in Unresectable Locally Recurrent or Metastatic Head and Neck Cancer

Date Added
January 14th, 2026
PRO Number
Pro00149057
Researcher
John Kaczmar

List of Studies


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

This study is for patients diagnosed with unresectable locally recurrent or metastatic head and neck cancer. The purpose of this study is to test if adding an investigational drug called amivantamab to the usual chemotherapy (carboplatin and paclitaxel) is more effective in treating head and neck cancer when compared to being treated with carboplatin and paclitaxel alone. Carboplatin and paclitaxel are FDA approved to treat head and neck cancers; however, adding the study drug, amivantamab, is still being investigated and is not approved by the FDA.

Patients may participate in this study for up to 2 years. Procedures include CT, MRI, blood tests, chemotherapy, and regular visits with your doctor including follow-up study visits or phone calls every 3 months. There will be about 50 people taking part in this study, approximately 3 participants will be enrolled at MUSC.

Risks include constipation, nausea, rash, vomiting, swelling of arms and/or legs. Participants may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Perinatal Mental Health and Trauma-Informed Care: Assessing mental health symptoms, treatment seeking, and intervention needs

Date Added
January 7th, 2026
PRO Number
Pro00147901
Researcher
Cristina Lopez

List of Studies


Keywords
Mental Health, Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

This study aims to explore the prevalence of mental health symptoms, including trauma exposure and posttraumatic stress symptoms in a postpartum population. The study also aims to collect information related to medical and mental health treatment seeking before, during, and after pregnancy as well as feedback on adaptations of future mental health interventions delivered during the postpartum period. Participation in this study includes a 35 minute online survey with questionnaires related to the study aims. Depending on survey responses, participants may be invited to complete an interview with study personnel to provide more specific insight on mental health treatments for perinatal individuals.

Institution
MUSC
Recruitment Contact
Cassidy Chesnutt
843-879-8749
brydonch@musc.edu

A012303: ShortStop-HER2: Shortened Duration of Adjuvant Therapy in Patients with Early-Stage HER2+ Breast Cancer Who Achieve pCR After Neoadjuvant Chemotherapy with HER2 Blockade

Date Added
December 15th, 2025
PRO Number
Pro00148356
Researcher
Abirami Sivapiragasam

List of Studies

Keywords
Cancer, Women's Health
Summary

This study is for patients who have been diagnosed with early-stage HER2-positive breast cancer and and have recently completed chemotherapy in combination with trastuzumab, followed by breast surgery. The chemotherapy plus trastuzumab produced a pathologic complete response (pCR), meaning that no remaining cancer was found during your breast surgery.

This study is testing two different durations of treatments on a drug called trastuzumab (with or without pertuzumab). Participants in this study will be randomly assigned, like flipping a coin, to receive either 6 months or 12 months of HER2-targeted therapy. Randomization means the study treatment group is chosen by chance, not by the participant or the doctor.

The primary purpose of this study is to find out whether a shorter 6-month course of HER2-targeted therapy works as well as the standard 12-month course at preventing the cancer from returning.

The study drug is given to participants through an intravenous (IV) infusion.

Participants can expect to be in the study for 6 to 12 months on active treatment, and up to an additional 10 years for post-treatment follow-up visit. There will be a total of 7 patients enrolled locally over the course of 31 months.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinicaltrials@musc.edu



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