A Study of GRC 54276 in Participants With Advanced Solid Tumors and Lymphomas.
Advanced Solid TumorLymphomaThis is first in human (FIH) study to a) evaluate the safety and tolerability profile of GRC54276, b) determine the maximum tolerated dose (MTD) and recommended Phase 2 doses (RP2D), and c) pharmacokinetic profile of GRC54276 alone and in combination with pembrolizumab or atezolizumab in participants with advanced solid tumors and lymphomas.
A Study of GIC-102 (Allogeneic Natural Killer Cells) in Patients With Advanced Solid Tumors, Non-Hodgkin...
Advanced Solid TumorsRelapsed/Refractory Non-Hodgkin Lymphoma1 moreThis is a first-in-human trial to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor effects of GIC-102 in patients with advanced solid tumors, relapsed/refractory non-hodgkin lymphoma, and multiple myeloma.
Graft Reinforcement for Posterior Nasal Nerve Neurectomy in Allergic Rhinitis Surgeries
NeurectomyRhinitis is defined clinically as having two or more symptoms of anterior or posterior rhinorrhea, sneezing, nasal blockage and/or itching of the nose during two or more consecutive days for more than 1 h on most days. Allergic rhinitis is diagnosed when these symptoms are caused by allergen exposure leading to an IgE mediated reaction. The inflammatory mediators produced because of this IgE mediated reaction causes the classical symptoms of allergic rhinitis. Nerve irritation causes sneezing and itching, the loss of mucosal integrity causes rhinorrhea, and the vascular engorgement leads to nasal blockage. Based on the nasal symptoms the prevalence of allergic rhinitis in the Indian population is 20-30%. Allergic rhinitis significantly affects the quality of life, it contributes to missed or unproductive time at school or work, disturbed sleep pattern and daytime somnolence. The most popular and widely accepted treatment strategy for allergic rhinitis is pharmacotherapy, this includes antihistamines, leukotriene receptor antagonist and intranasal corticosteroids. These medical modalities are symptomatically effective in mild cases, with temporary relief and addressable adverse effects. Prolonged treatment with allergy immunotherapy causes a sustainable financial burden while remaining inaccessible at smaller towns. Rhinorrhea is a frequent symptom reported amongst patients with allergic and vasomotor rhinitis. Most of these patients usually respond well to medical treatment. Indications for surgical treatment are warranted only when medical treatment fails, or a patient wants a permanent solution. In 1961, Golding-Wood first described vidian neurectomy for the treatment of allergic and vasomotor rhinitis. There was a high incidence of post-operative complications, such as disturbed lacrimal secretion and numbness of the cheek and gums. In 2007, Kikawada reported an endoscopic technique involving resection of the posterior nasal nerve near the sphenopalatine artery. With this technique, any intra-operative bleeding can be controlled under direct vision. In 2008, Ikeda et al. described submucosal reduction of the inferior turbinate and resection of the posterior nasal nerve. This resulted in significant improvements in nasal symptoms for patients with resistant chronic rhinitis (rhinorrhea). The posterior nasal nerve is a peripheral branch of the sphenopalatine ganglion. It enters the nasal cavity through a separate foramen, 4-5 mm below the sphenopalatine foramen, after bifurcation of the nerve into the lacrimal nerve. The posterior superior nasal nerves innervate the superior and middle turbinates, and the superior and middle meatus. Other parasympathetic nerve fibres of the nose branch off and joins the greater palatine nerve and enters the nasal cavity through the canaliculi in the perpendicular plate of the palatine bone as the posterior inferior nasal nerves. These nerves innervate the inferior turbinate and the inferior meatus.
Evaluation of IGM-2644 in Adults With Relapsed and/or Refractory Multiple Myeloma
Multiple MyelomaThis is a first in human, phase 1, multicenter, open-label study to determine the safety and tolerability of IGM-2644 as a single agent in participants with relapsed and/or refractory MM, for whom standard therapy does not exist, has proven to be ineffective or intolerable, or is considered inappropriate. Dose escalation and dose expansion cohorts will be enrolled to evaluate safety, preliminary efficacy, and further define a RP2D. The total length of the study, from screening of the first participant to the end of the study, is expected to be approximately 60 months.
A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily...
HIV InfectionsThis is a multicentre study carried out in participants living with human immunodeficiency virus type 1 (HIV-1) who have not previously been treated with any antiretroviral therapies. The study will investigate two 2-drug regimens for the treatment of HIV-1: a fixed-dose combination oral tablet of dolutegravir/lamivudine (DTG/3TC) and cabotegravir plus rilpivirine long-acting agents (CAB + RPV LA). All participants will initially receive DTG/3TC once daily, and once virologic suppression is attained (plasma HIV-1 <50 c/mL), participants will be offered a choice to switch to CAB + RPV LA or to continue taking oral DTG/3TC. This study will provide important data on the efficacy, safety, implementation effectiveness, and patient-reported outcomes of these two regimens in a study where participants have the option to choose between them based on individual preference. The aim of the study is to evaluate the antiviral effectiveness at 11 months after switching to CAB+RPV LA following initial virologic suppression on DTG/3TC and to provide data on how long it takes participants to suppress their viral load on DTG/3TC.
Zanubrutinib Plus BR in Newly Diagnosed Symptomatic WM
Waldenstrom MacroglobulinemiaThis study aims to evaluate the long-term efficacy of BTK inhibitor Zanubrutinib combined bendamustine and rituximab (ZBR) for time-limited treatment of Waldenstrom macroglobulinemia, The combination therapy is expected to improve the remission depth, prolong the remission time, and improve the progression-free survival and overall survival of newly diagnosed WM patients. On the one hand, the patients have to bear a long-term economic burden, which is often difficult for some patients to adhere to for a long time. On the other hand, in the course of long-term treatment of BTKi, drug resistance and intolerable side effects are prone to occur. At the same time, it can prevent the disease rebound after the withdrawal of BTKi, so as to achieve the phased withdrawal of WM
SVRd for the Treatment of Newly Diagnosed Multiple Myeloma Patients Presenting With Extramedullary...
Multiple MyelomaThe purpose of this study is to evaluate the efficacy and safety of SVRd in NDMM patients presenting with extramedullary disease.
Cord Blood Transplant in Adults With Blood Cancers
Acute Myelogenous Leukemia (AML)Acute Lymphoblastic Leukemia (ALL)4 moreCord blood transplants (CBT) are a standard treatment for adults with blood cancers. MSK has developed a standard ("optimized") practice for cord blood transplant (CBT). This optimized practice includes how patients are evaluated for transplant, the conditioning treatment (standard chemotherapy and total body irradiation therapy) given to prepare the body for transplant, the amount of stem cells transplanted, and how patients are followed during and after transplant.The purpose of this study is to collect information about participant outcomes after CBT following MSK's optimized practice. The researchers will look at outcomes of the CBT treatment such as side effects, disease relapse, GVHD, and immune system recovery after CBT treatment.
A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC...
Metastatic Castrate-sensitive Prostate CancerThe purpose of the study is to determine if the intermittent use of androgen-deprivation therapy (ADT) in participants with metastatic castrate-sensitive prostate cancer (mCSPC) who reached a prostate-specific antigen (PSA) level < 0.2 nanograms/millilitres (ng/mL) after 6 months of treatment with apalutamide and ADT combination therapy provides non-inferior radiographic progression-free survival (rPFS) and a reduced burden of hot flashes measured as 18-month percent change in severity adjusted hot flash score.
In Vivo Efficacy of Salbutamol (Sandoz) Versus Salbutamol Ventolin (GSK) in Children With Asthma...
AgentsAnti Asthmatic1 moreIn this study, the investigators hypothesize that the reference product (SalbR/Ventolin) is more effective than SalbG (Salbutamol Sandoz) at improving the lung function in children with asthma, and that this difference increases alongside the severity of the airway resistance. (Null hypothesis: There is no difference). This could be explained by different properties and deposition of the aerosol. Purpose of this research: Rejecting the null hypothesis. This is based on the answers to the questions below. Research questions: Is there a difference between the increase in FEV1 (and FVC) after 100 μg SalbG versus FEV1 after 100 μg SalbR in children aged 4-14 years with insufficient asthma control? (primary question) Is there a difference in the subjective feeling of the children after inhalation with 100 μg SalbR and after 100 μg SalbG, measured with a VAS score? Is the increase in FEV1 (and FVC) in children with asthma between 4-14 years of age with insufficient asthma control after inhalation of 400 μg SalbR different than after inhalation of 400 μg SalbG? Is there a difference in the subjective feeling of the children after inhalation with 400 μg SalbR and after 400 μg SalbG, measured with a VAS score?