Huntersville

Researchers are investigating the possibility of collecting, growing, and selecting specific T lymphocytes from both cancer patients and healthy volunteers. The goal is to identify PD-1+ and CTLA4+ T cells and other immune cell types from the blood using targeted antibodies. These selected cells are then tested outside the body to see how well they can attack the patient's own tumor cells. This study includes both adults with various solid tumors at different disease stages and healthy volunteers, including children with COVID-19 for limited sample collection. Participants may undergo procedures to collect blood cells, especially leukapheresis, which separates white blood cells from the blood. For leukapheresis, additional health requirements such as blood counts and organ function tests must be met. Healthy volunteers aged 5 and older may participate in less invasive sample collections like swabs, saliva, or urine. The study involves careful screening for infections and blood-borne viruses to ensure safety and reliable results. Throughout the study, participants provide biospecimens that are analyzed for immune cell function and cancer-fighting ability. Participants' health status, including blood tests and pregnancy tests for women, will be monitored to meet safety criteria. The study aims to better understand immune cells in cancer and healthy individuals, potentially aiding future immune-based therapies. Participation durations and specific procedures depend on the cohort and collection method used.

This research focuses on participants with narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. It is a long-term extension study following a previous trial, aiming to evaluate the long-term safety, tolerability, and effectiveness of the drug ORX750 in these conditions. The study is part of a Phase 2 clinical trial program specifically involving participants who completed the initial parent study. Participants will receive oral ORX750 during the long-term extension period. This open-label study continues treatment with ORX750, allowing researchers to observe its effects over an extended time without a placebo comparison. The study builds upon prior treatment to assess ongoing outcomes and safety. During the study, participants will be closely monitored for any treatment-emergent adverse events, serious adverse events, abnormal lab tests, changes in vital signs, abnormal ECG results, and any signs of suicidal thoughts or behavior up to day 70. The study requires participants to adhere to protocol requirements and will assess their continued safety and response to ORX750 throughout the treatment period.

Researchers are evaluating the long-term safety, tolerability, and lasting effects of ALKS 2680 tablets in adults aged 18 to 70 years with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia. This study continues from earlier trials and aims to monitor how well the treatment works and how safe it is over an extended period. Participants receive daily oral doses of ALKS 2680 tablets in varying strengths ranging from 4 mg to 18 mg. The study is an open-label, long-term extension, meaning all participants know they are receiving ALKS 2680 as they continue treatment after completing a prior parent study. The dose is administered once daily, and the study focuses on ongoing monitoring rather than comparing to a placebo. During the study, participants are regularly assessed for any treatment-emergent adverse events up to 100 weeks. Safety evaluations include clinical assessments, laboratory tests, and monitoring for any new health issues. Researchers track the ability to tolerate the medication and the durability of its effect on symptoms. This long-term follow-up helps ensure comprehensive understanding of the treatment's impact over time.

Researchers are evaluating JMT108, a bispecific antibody drug, in adults with locally advanced or metastatic solid tumors who have not responded to or cannot tolerate standard treatments. This Phase 1 trial aims to assess the safety, tolerability, and appropriate dosing schedule of JMT108, as well as its effectiveness and how the body processes the drug. The study also explores the development of antibodies against JMT108, its pharmacodynamic properties, and potential links between biomarkers and treatment response. The study has two parts: Phase 1a involves dose escalation using a BOIN design with four dose levels (0.1, 0.3, 1, and 2 mg/kg) given by intravenous injection every two weeks. Dose escalation decisions are based on dose-limiting toxicities observed. After determining the recommended dose, Phase 1b expands cohorts based on tumor type, including lung, colorectal, liver, gastric, melanoma, and other advanced solid tumors. Participants receive JMT108 intravenously every two weeks until the doctor decides to stop treatment. Participants provide informed consent, undergo screening to confirm eligibility, and attend regular study visits. The study monitors tumor response using RECIST criteria and tracks dose-limiting toxicities for up to one year. Participants are followed for disease progression every three months for up to two years. Safety, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity are evaluated throughout the study.

Researchers are evaluating CRB-701, an antibody-drug conjugate targeting nectin-4, in adults with advanced solid tumors that express nectin-4. This Phase 1/2 clinical trial aims to find a safe and effective dose of CRB-701 and to determine which cancers might respond to this treatment. The study includes three parts focusing on safety, dosing, and effectiveness, especially for tumors resistant to other treatments or lacking standard therapies. The study is divided into three parts. Part A involves escalating doses of CRB-701 alone to identify the maximum tolerated dose and recommended dose for further study. Part B tests two dose levels of CRB-701 alone and combined with an anti-PD-1 checkpoint inhibitor to optimize dosing. Part C further explores CRB-701 alone or with anti-PD-1 in up to seven groups of participants. Treatments are given by intravenous infusion. Participants will attend clinic visits for infusions and undergo various tests including blood work, CT or MRI scans, and other assessments to monitor tumor response and safety. The main outcomes measured are dose safety, tolerability, and objective tumor response over periods ranging from 21 days to up to 6 months. Ongoing monitoring includes safety assessments and evaluation of treatment effects over time.

Researchers are conducting a Phase 1/2 open-label, multicenter trial to evaluate TER-2013 in patients with advanced solid tumors that have alterations in the AKT/PI3K/PTEN pathway. The study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of TER-2013 both alone and combined with fulvestrant. This first-in-human trial seeks to determine the maximum tolerated dose and preliminary clinical benefits of these treatments. The study comprises two parts: Part 1 involves dose escalation of TER-2013 given as oral capsules, administered alone or with fulvestrant injections (500 mg intramuscularly). Part 2 is a dose expansion phase to further explore treatment effects. Patients receive treatment according to their group, with specific cohorts for various tumor types including ovarian, cervical, squamous cell carcinomas, and hormone receptor-positive breast cancer. Participants undergo evaluations of tumor lesions using RECIST v1.1 criteria, as well as monitoring for dose-limiting toxicities and treatment-related adverse events over up to two years. Researchers will measure objective response rates and duration of response during this period. Safety assessments, organ function tests, and performance status checks are part of ongoing study monitoring to understand treatment impact and tolerability.

Researchers are evaluating the efficacy and safety of HBS-301 in treating symptoms of idiopathic hypersomnia (IH), including excessive daytime sleepiness, sleep inertia, and fatigue. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on adults aged 18 years and older diagnosed with IH. The study aims to compare HBS-301 to a placebo in relieving these symptoms and to assess its overall safety profile. Participants will be randomly assigned to receive either HBS-301 tablets or matching placebo tablets during an 8-week double-blind treatment period. Before this, there is a screening and baseline period lasting up to 28 days. Following the double-blind phase, participants have the option to join a one-year open-label extension period where they may receive HBS-301. After completing treatment, a 30-day safety follow-up will monitor participants for any adverse effects. Throughout the study, participants will undergo various assessments including sleep studies and symptom evaluations to measure the effectiveness of HBS-301. Researchers will track changes in idiopathic hypersomnia symptoms from baseline through the end of the double-blind period. Safety will also be closely monitored during treatment and follow-up periods to ensure participant well-being over the course of the study, which may last over a year for those in the extension phase.

This research aims to evaluate the effectiveness, safety, and tolerability of two doses of remibrutinib compared to placebo in people aged 12 years and older with moderate to severe hidradenitis suppurativa, a chronic skin condition. The study is a phase 3 clinical trial involving participants with a diagnosis lasting at least six months and active symptoms in multiple body areas. The purpose is to determine how well remibrutinib works and how safe and tolerable it is for this condition. The trial lasts a total of 76 weeks and includes several parts: a screening period of up to 4 weeks, a first treatment period of 16 weeks where participants receive either remibrutinib Dose A, Dose B, or placebo in a double-blind manner, followed by a second treatment period lasting 52 weeks during which all participants receive remibrutinib doses. After treatment, there is a 4-week safety follow-up without treatment. Participants stopping treatment early are encouraged to continue in the study and complete the safety follow-up. During the study, participants will be regularly monitored for their response to treatment, including the proportion who achieve a clinical response measure called HiSCR50 at Week 16. Assessments will include physical exams and safety checks throughout the treatment periods and follow-up. The study seeks to gather detailed information on how remibrutinib affects the severity of hidradenitis suppurativa and participants' overall health during and after treatment.

Researchers are evaluating the safety and effectiveness of fixed dose combinations of ensifentrine with two different doses of glycopyrrolate compared to placebo and each drug alone in adults with chronic obstructive pulmonary disease (COPD). This phase IIb study focuses on measuring lung function improvements using bronchodilator effects in people with COPD. Participants have a history of smoking and meet specific lung function criteria to be included. Participants will be randomly assigned to one of six groups: two combination treatments of ensifentrine (3 mg) with glycopyrrolate at either 21.25 or 42.5 mcg, each drug alone as monotherapy, or placebo. All treatments are given twice daily for 28 days using a standard jet nebulizer. The study includes 1 to 2 weeks of screening, 4 weeks of treatment, followed by 1 week of follow-up. During the study, participants will undergo lung function testing at baseline and on days 1, 14, 28, and 29 to measure changes in forced expiratory volume in one second (FEV1). They will also have chest X-rays or CT scans reviewed, complete questionnaires on breathlessness, and have regular assessments to monitor safety and treatment effects. Participants must be able to use the nebulizer properly and attend all study visits over approximately 7 weeks.

Researchers are evaluating the SureSmile clear aligner medical device in a three-armed, multicenter clinical study focused on patients with dental malocclusion. The primary goal is to confirm the safety and assess the accuracy of different tooth movements during treatment. The study also compares three different aligner trimline designs: Scalloped, Straight, and Straight Extended. Participants will be treated using SureSmile Clear Aligners, which are custom-made devices designed to fit different mouth shapes and sizes. The study groups differ only by the trimline design used on the aligners. All other pre-treatment, treatment, and post-treatment procedures and materials are the same across groups. Treatment duration typically ranges from 6 to 18 months, depending on the individual treatment plan. During the study, participants will undergo assessments of tooth movement accuracy at the beginning and end of the treatment period. Researchers will monitor the progress through clinical visits and follow-ups, evaluating how well the aligners achieve the planned tooth positions. Safety and adherence to treatment protocols will also be observed throughout the study period.