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 Phase 2, Open-Label, Randomized, Global Study of Three Telisotuzumab Vedotin Regimens in Subjects with Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer

Date Added
December 30th, 2025
PRO Number
Pro00147394
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Drug Studies
Summary

This is a Phase II clinical trial testing a drug called Telisotuzumab Vedotin in people who have already been treated for a specific type of lung cancer that has spread or is hard to remove with surgery. The cancer must show high levels of a protein called c-Met and have a normal version of another protein called eGFR. The main goal is to see how well the drug works and how safe it is when given in three different ways. Telisotuzumab Vedotin is a special kind of medicine that combines an antibody (which targets cancer cells) with chemotherapy. It's given through an IV (a tube in your vein), and each treatment takes about 30 minutes. Patients will get this treatment every two weeks on day one of the cycle. There will be four cycles in the study. There is also a 28 day screening window, a 30 day follow up period, post treatment follow up, and then survival follow up. The study itself will only last a few months, but the follow up will last for years. The follow up period will have limited contact compared to the main study. There will be around about 10 total study visits.

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

A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination with Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination with Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Date Added
December 18th, 2025
PRO Number
Pro00147387
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Drug Studies
Summary

This study is for patients that have been diagnosed with non-small cell lung cancer (NSCLC). This study is testing an investigational drug called Amivantamab. "Investigational" means that is not been approved by United States Food and Drug Administration (FDA). There will be no randomization in this study. Participants will be assigned to treatment upon enrollment based on disease treatment status. The primary purpose of this study is to understand how well the study treatment works and the safety of the combination of Amivantamab and Lazertinib in participants who have NSCLC with a specific eGFR mutation. Amivantamab can be given under the skin (subcutaneous) or by infusion (IV). Participants can be in the study for up to 36 months depending on how the participants disease responds to treatment.

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

A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing Olpasiran Use to Prevent First Major Cardiovascular Events in Participants with Elevated Lipoprotein(a)

Date Added
December 9th, 2025
PRO Number
Pro00147257
Researcher
Ashley Waring

List of Studies

Keywords
Drug Studies, Heart
Summary

This study is enrolling participants with risk factors for heart or blood vessel events (e.g. heart attack, stroke, etc) who also have an elevated lipoprotein a (Lp(a)), which is a sticky particle in the blood that carries cholesterol. The first part of the study involves testing the Lp(a) level and if elevated then participants will be invited to be a part of a study testing the investigational medication olpasiran. Investigational means it has not been approved for commercial use by the Food and Drug Administration. The study medication is given as a shot just under the skin every 3 months. This study is a randomized study meaning participants are assigned by chance to either receive olpasiran or placebo. Placebo looks like the real medication but has no active ingredients. Participants have a 50:50 chance of being assigned to either group but will not know which group they are in. Study related procedures include physical exams, blood work, vital signs, electrocardiogram (ECG - a tracing of the heart's electrical activity) and study medication administration. This study is expected to last about three and a half to five and a half years and involve between 16 to 28 visits.

Institution
MUSC
Recruitment Contact
Olivia Washington
843-792-5863
Washoliv@musc.edu

A Phase 3, Open-Label, Multicenter, Extension Study of Acoramidis in Patients with Newly Diagnosed Variant Transthyretin Amyloid Cardiomyopathy (ACT-EARLY OLE)

Date Added
December 9th, 2025
PRO Number
Pro00148422
Researcher
Jan Griffin

List of Studies

Keywords
Cardiovascular, Drug Studies, Heart
Summary

This study is an open label extension of the ACT-EARLY study. which included those with no evidence of ATTR but are known carriers of disease causing TTR gene. ATTR stands for transthyretin amyloidosis. It is a condition in which a protein called transthyretin (TTR) accumulates in various organs, including the heart (known as ATTR-CM), kidneys, and nerves (known as ATTR-PN). This accumulation can lead to damage and dysfunction in these organs.

This study will continue using the study drug acoramidis (AG-10) to determine if it can help people with the genetic TTR variant slow the progression of ATTR. AG-10 is an investigational drug. Investigational means that AG-10 is not yet approved for use in any settings outside of clinical research studies like this one. Reducing the amount of TTR in your blood may reduce the amount of amyloid deposits in your body and may keep your cardiomyopathy from getting worse over time.

Participation in this study will last up to 60 month and will consist of about 13 clinic visits and about 11 telephone follow up visits. Some tests required include physical exams, medical and surgical history, bloodwork, questionnaire, electrocardiogram (test that records your heart's electrical activity), echocardiogram (ultrasound test of your heart) and study drug administration.

Institution
MUSC
Recruitment Contact
Natalie Drain
843-876-5037
drain@musc.edu

Randomized Phase III Trial of Pembrolizumab vs. Pembrolizumab/Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Platinum Refractory Disease

Date Added
November 18th, 2025
PRO Number
Pro00147980
Researcher
John Kaczmar

List of Studies


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

The purpose of this study is to test whether adding cetuximab to standard of care (pembrolizumab) is more effective in shrinking tumor size and increasing survival when compared to being treated with pembrolizumab alone. This study seeks to find if this approach is the same, better, or worse than standard of care for returning or spreading head and neck cancer after previous treatment.

Treatment and follow up for this study may be up to 5 years. The procedures include blood tests, CT or MRI scans, and chemotherapy. Risks include tiredness, anemia, constipation, loss of appetite, joint stiffness, cough, swelling and redness of the skin.

You 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. Both drugs, pembrolizumab and cetuximab, are already individually approved by the FDA for use in head and neck cancers. However, the benefit of combining the two drugs is being investigated in this study and this study approach is not FDA approved.

There will be about 158 people taking part in this study, approximately 4 subjects will be enrolled at MUSC.

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

A Randomized Phase II Study of Nivolumab versus Nivolumab and BMS-986016 (Relatimab) as Maintenance Treatment after First-line Treatment with Platinum-Gemcitabine-Nivolumab for Patients with Epstein-Barr Virus- Associated Recurrent/Metastatic Nasopharyngeal Carcinoma (REMAIN)

Date Added
November 14th, 2025
PRO Number
Pro00146870
Researcher
John Kaczmar

List of Studies


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

This study is for subjects who have been diagnosed with recurrent or metastatic nasopharyngeal cancer. Subjects are expected to remain in the study for a minimum of 70 months. Drugs are FDA approved and is given through a vein (also called IV or intravenous). The procedures include blood and urine tests, troponin test. Risks include infection, bruising, bleeding, anemia, kidney damage, hearing loss, nausea, vomiting, numbness, pain, rash, blood in urine. You may not receive a 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

GAIN-BCG: Gemcitabine Alternating With Intravesical BCG Randomized Against BCG Alone For Patients With Recurrent High Grade Non-Muscle Invasive Bladder Cancer

Date Added
October 28th, 2025
PRO Number
Pro00147104
Researcher
Robert Grubb

List of Studies


Keywords
Cancer/Genitourinary, Drug Studies
Summary

This study is for people with high-risk, non-muscle invasive bladder cancer that has returned after treatment with BCG. Your cancer either did not fully respond to BCG or came back after initially responding, which is called BCG-exposed NMIBC. The purpose of this study is to find out if adding a chemotherapy drug called gemcitabine, given directly into the bladder through a catheter, to BCG works better than BCG alone. In this study, you will either receive BCG alone for up to 6 weeks or gemcitabine plus BCG for up to 10 weeks, called induction therapy. If the treatment is effective, you may continue with maintenance therapy, which is either BCG alone or gemcitabine plus BCG given over several weeks. After treatment, your doctor will monitor you for 5 years with regular checkups, cystoscopies, and CT scans to watch for side effects or recurrence. The main risks are that the study treatment may not work as well as usual care, and it may cause side effects such as pain with urination, urinary urgency, blood in the urine, bladder inflammation, or urinary tract infection. There may also be risks that study doctors do not yet know about.
There will be a total of 17 patients enrolled locally over the course of 42 months.

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

A Phase 3, Two-part, Randomized, Open-label, Adaptive Study Comparing BMS-986365 versus Investigator's Choice of Therapy Comprising Either Docetaxel or Second Androgen Receptor Pathway Inhibitor (ARPI), in Participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) - rechARge

Date Added
October 8th, 2025
PRO Number
Pro00144193
Researcher
Theodore Gourdin

List of Studies


Keywords
Cancer/Genitourinary, Drug Studies, Men's Health, Prostate
Summary

This study is for male subjects that have been diagnosed with metastatic prostate cancer (that has spread to other parts of the body) and progressed following standard hormonal/radiation therapy and surgery. Subjects are expected to remain in the study for a minimum of 48months or longer. There will be a total of 10 subjects locally enrolled.

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

NRG-CC014: Radiation Therapy for High-Risk Asymptomatic Bone Metastases: A Pragmatic Multicenter Randomized Phase 3 Clinical Trial (Preempt)

Date Added
September 23rd, 2025
PRO Number
Pro00146746
Researcher
Brian Lally

List of Studies

Keywords
Cancer/Genitourinary, Drug Studies
Summary

The purpose of this research study is to find out if giving radiation therapy (RT) early to high-risk bone metastases that are not causing pain can reduce the chance of skeletal-related events (SREs) such as fractures, spinal cord compression, or surgery to bone. This will be compared to the current standard of care (SOC), which usually treats bone metastases only when symptoms like pain occur. The study will enroll 16 participants locally over 25 months, and each subject will remain in the study for at least 40 months. You are being asked to join because you have metastatic cancer that has spread to your bones and is considered "high-risk," though it is not causing pain at this time. High-risk bone metastases are typically located in the spine, hip, shoulder, or long bones, and larger tumors in these areas are more likely to cause complications. If you join this study, you will receive radiation therapy to high-risk bone sites in addition to standard care. The main risk is that radiation therapy may not work better than the usual approach at preventing bone complications. Radiation can also cause side effects, including skin changes, tiredness, and inflammation of the esophagus, bowel, or lungs. There may also be risks that are not yet known to the study doctors.

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



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