A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of ITK Inhibitor Soquelitinib Versus Physicians Choice Standard of Care Treatment (Selected Single Agent) in Participants with Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma

Date Added
September 14th, 2026
PRO Number
Pro00150126
Researcher
Ashwath Gurumurthi

List of Studies

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

This study is for patients diagnosed with relapsed or refractory T-cell lymphomas. These include:

Peripheral T‑cell lymphoma, not otherwise specified (PTCL-NOS)

Follicular helper T‑cell lymphoma (TFH lymphoma)

Systemic anaplastic large‑cell lymphoma (sALCL)

The study is testing a drug called Soquelitinib. This drug is investigational, which means it has not been approved by the U.S. Food and Drug Administration (FDA).
The purpose of the study is to see how well soquelitinib works compared with standard treatment chosen by a physician. Standard treatment may include:

Belinostat (BELEODAQ®)

Pralatrexate (FOLOTYN®)

The study may last up to 6 years. Study treatment may last up to 2 years (104 weeks). Study visits will happen based on the treatment schedule for the assigned study drug.About 180 people will be screened for the study. About 150 participants will be randomly assigned to a treatment group.Soquelitinib works by blocking an enzyme called ITK. ITK is part of a signaling pathway that helps certain cancer cells grow. Blocking ITK may slow or stop the growth of cancer T cells.
Soquelitinib has not been approved for use in humans and is considered experimental. It is not known if the drug will work for this cancer. The possible side effects are also not fully known. About 70 patients have received soquelitinib in another clinical trial. In those patients, the drug was generally tolerated.In this study, treatment with soquelitinib will be compared with standard treatments used for this type of cancer.Belinostat is approved in the United States for adults with relapsed or refractory PTCL.Pralatrexate is approved in several countries, including the United States, Canada, Australia, and South Korea, for patients with relapsed or refractory PTCL.
Participants will be placed into treatment groups by randomization. Randomization means assignment to a group by chance, similar to flipping a coin. Each participant has an equal chance of receiving any of the study treatments.

Institution
MUSC
Recruitment Contact
Hannah Mendiola
843-792-9321
hcc-clinicaltrials@musc.edu

Clinical Outcomes and Psychosocial Impacts of CRMS in an MUSC Cohort

Date Added
September 11th, 2026
PRO Number
Pro00152397
Researcher
Dylan Pfendler

List of Studies

Keywords
Non-interventional
Summary

This study aims to improve our understanding of Cystic Fibrosis Transmembrane Conductance Regulator(CFTR)-related metabolic syndrome(CRMS), a term used for some infants whose newborn screening results suggest they may be at risk for cystic fibrosis but who do not currently meet the criteria for a cystic fibrosis diagnosis. CFTR stands for cystic fibrosis transmembrane conductance regulator and refers to a gene that provides instructions for making a protein that helps control the movement of salt and water in and out of cells. Changes in this gene can increase a person's risk of developing cystic fibrosis or related health concerns.

The study has two goals. First, we will review existing medical records to better understand the health conditions, symptoms, and long-term health of children with CRMS and adults with cystic fibrosis diagnosed later in life who receive care at the Medical University of South Carolina pulmonary clinic. Second, we will survey parents of children with CRMS to better understand how receiving a CRMS designation affects families emotionally and in their daily lives.

Institution
MUSC
Recruitment Contact
Dylan Pfendler
(585)820-4470
pfendler@musc.edu

ATHNdataset Registry

Date Added
September 11th, 2026
PRO Number
Pro00151458
Researcher
Shayla Bergmann

List of Studies


Keywords
Blood Disorders
Summary

The ATHNdataset Registry is the largest blood disorders real-world data set in the United States and is used to answer important clinical and scientific questions about the specific causes, prevention, treatment, and the social and economic impact of blood disorders.

The registry will involve collecting health information from the medical records, bleeding and treatment records of participants, and completion of questionnaires. This information will be part of the ATHNdataset registry which will be used to answer scientific, public health, and policy questions about better ways to treat blood disorders.

Institution
MUSC
Recruitment Contact
Shayla Bergmann
843-812-5682
bergmans@musc.edu

A seamless Phase 2/3 randomized, open-label study to investigate efficacy and safety of frexalimab versus tacrolimus in adult kidney transplant recipients

Date Added
September 11th, 2026
PRO Number
Pro00149971
Researcher
Prince Anand

List of Studies

Keywords
Kidney, Transplant
Summary

This research study is being done to compare the effectiveness and safety of frexalimab, a medication given as an injection under the skin every 4 weeks, with tacrolimus, a commonly used anti-rejection medication taken by mouth. The study will include adults ages 18 to 70 who are receiving their first kidney transplant and have a low to moderate risk of rejecting the transplanted kidney. Participants who qualify may take part in the study for up to 5 years.

Institution
MUSC Health Lancaster Medical Center
Recruitment Contact
Darann Wiegand
803-286-1385
Wiegandd@musc.edu

Characterizing the immune profile in osteogenesis imperfecta patients.

Date Added
September 11th, 2026
PRO Number
Pro00147003
Researcher
Meenal Mehrotra

List of Studies


Keywords
Bone, Genetics, Immune System, Inflammation, Rare Diseases
Summary

In our preclinical mouse studies we have identified immune dysfunction in mouse models of osteogenesis imperfecta, also known as brittle bone disease. We then successfully restored bone strength in these mice with our patented adoptive cell therapy treatment.

In this study we will collect small volume blood samples from patients with osteogenesis imperfecta. We will then analyze these blood samples through a variety of methods to determine if osteogenesis imperfecta patients have the same immune dysfunction as we have seen in our mice studies.

Institution
MUSC
Recruitment Contact
Meenal Mehrotra
860-593-9842
mehrotra@musc.edu

A Multi-Center, Randomized, Controlled, Pivotal Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device in Patients with Acute Kidney Injury Requiring Kidney Replacement Therapy

Date Added
September 10th, 2026
PRO Number
Pro00149667
Researcher
Blaithin McMahon

List of Studies


Keywords
Kidney
Summary

AKI is a condition where the kidneys are not able to make enough urine. Therefore, another way to remove waste from the body is needed. One way of removing waste from the body is called Continuous Kidney Replacement Therapy (CKRT). There are different types of CKRT, but all allow waste to be removed from your body because the kidneys can not do this any longer. Acute kidney injury can also cause your immune system to not work correctly and this may be one of the reasons that AKI is such a deadly condition. White blood cells, which are key parts of the immune system, are overactive in AKI and may be the reason the immune system doesn't work the way it should. The experimental device is a Selective Cytopheretic Device (SCD). It is a set of tubing and a cartridge that is connected in series to a CKRT circuit. The SCD binds and stops overactive white blood cells. The purpose of this study is to test if the SCD helps someone with AKI recover faster than without it.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
(843) 792-0965
recruitment@musc.edu

Healthcare experience and needs among loved ones of violently injured patients

Date Added
September 9th, 2026
PRO Number
Pro00149490
Researcher
Ashley Hink

List of Studies

Keywords
Critical Care
Summary

The purpose of the study is to better understand the experience of loved ones whose family members were treated for violence injuries at MUSC, and what services could potentially be improved. This study will involve administering surveys to loved ones of patients who are treated for injuries due to intentional violence at MUSC. They will be recruited via flyers and information sheets. Survey questions will address perceptions of their loved ones healthcare experience, interactions with staff members, impact of the Turning the Tide Violence Intervention Program (TTVIP), what perceived needs they have, and what services have been provided. Responses of those that have loved ones who enrolled in TTVIP compared to those who did not will be compared to assess for differences.

Institution
MUSC
Recruitment Contact
Claire Jacoby
8437691689
jacobyc@musc.edu

Neoadjuvant Chemo-Cemiplimab for Clinical Stage I, 2-3.9cm, Non-Small Cell Lung Cancer

Date Added
September 8th, 2026
PRO Number
Pro00151547
Researcher
Barry Gibney

List of Studies


Keywords
Cancer/Lung
Summary

This study is for adult patients that have been diagnosed with stage I non-small cell lung cancer (NSCLC). The purpose of this study is to evaluate whether a drug called cemiplimab, used in combination with other standard therapies (chemotherapy) is safe and effective in treating early stage NSCLC. Cemiplimab is a FDA approved drug, but its use in this study is investigational. Participants will undergo standard procedures such as blood collection for laboratory testing, physical exams, and imaging. In addition to standard of care treatment, blood will be collected for research purposes and cemiplimab will be administered. Risks of being in this study include side effects from the drugs (such as nausea, vomiting, and low blood counts), loss of confidentiality, and bruising and/or bleeding from blood draws. Participation in this study is expected to last approximately five (5) years.

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

Topical Minocycline Foam for Treatment of Confluent and Reticulated Papillomatosis (CARP)

Date Added
September 8th, 2026
PRO Number
Pro00140636
Researcher
Lara Wine Lee

List of Studies


Keywords
Drug Studies, Skin
Summary

This study will look at whether a topical medication called minocycline foam (AMZEEQ) can help treat confluent and reticulated papillomatosis (CARP), a skin condition that causes dark, scaly patches. We will also evaluate how safe the treatment is and how satisfied patients are with it. The study is open to participants ages 9 years and older.

Participants will apply minocycline foam to one side of the affected skin and a moisturizing cream (emollient) to the other side for 5 weeks. This allows us to compare the two treatments in the same person. After this period, participants may choose to continue using the minocycline foam on all affected areas.

During the study, participants will attend follow-up visits where photos of the skin will be taken and the condition of the skin will be evaluated. Participants will also complete brief surveys about how their skin condition affects their quality of life and how satisfied they are with the treatment. The research team will monitor treatment use and any side effects.

The goal of this study is to learn whether topical minocycline could be a safe and effective treatment option for CARP, potentially providing an alternative to oral antibiotics.

Institution
MUSC
Recruitment Contact
Lara Wine Lee
610-715-4746
winelee@musc.edu

Mom Era, Reclaimed: Measuring Change in Stress, Wellbeing and Occupational Balance Among Student Moms

Date Added
September 3rd, 2026
PRO Number
Pro00152874
Researcher
Zesarae Bodie

List of Studies

Keywords
Women's Health
Summary

As a part of their 2nd year curriculum, OT students offer a virtual wellness program, for graduate students, aged 18+, who are parenting, and it is called Mom Era, Reclaimed. It is led by the students and facilitated by faculty. The program runs for 6 weeks and is designed to help student moms manage stress, feel more connected to themselves and others, and build daily routines that work better for their lives as both students and parents. This study seeks to learn whether this kind of program is helpful for student moms, so it can be improved and possibly offered to more students in the future.
Participating students will be surveyed at the beginning of the first session and then again at the end of the final session to measure change in their perceptions of their stress, wellbeing and occupational balance. Student moms do not have to participate in the survey to be a part of the the wellness group, the survey is optional and will not affect their participation in the larger group.

Institution
MUSC
Recruitment Contact
Zesarae Bodie
(843) 548-1036
bodiez@musc.edu



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