
Anti-CD19/CD22 Bispecific CAR-T Cell Therapy for MRD Positive ALL
MRD-positiveAcute Lymphoblastic LeukemiaTo evaluate the safety and efficacy of CD19/CD22 Bispecific CAR-T for the treatment of MRD-positive B cell acute lymphoblastic leukemia. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19/CD22 CAR+ T cells.

Influence of Dermocorticoids on Bone Mineral Density in Patients With Bullous Pemphigoid
OsteoporosisBullous PemphigoidBullous pemphigoid is the most common type of bullous skin disease and is clinically characterized by clear-tense bullae, which result in post-bullous cutaneous erosions, altering the skin barrier. The treatment of this pathology consists of the application of high doses of topical corticosteroids (clobetasol propionate) for a prolonged period of at least 6 months. The main objective of this study is to demonstrate a change in bone mineral density at 6 months after initiation of treatment, in subjects with bullous pemphigoid and treated with topical corticosteroid.

MEthotrexate Versus TOcilizumab for Treatment of GIant Cell Arteritis: a Multicenter, Randomized,...
Giant Cell ArteritisGiant-cell arteritis (GCA) is the most frequent vasculitis after 50 years. It is characterized by a granulomatous inflammation of the wall of large vessels, involving especially the aorta and extra-cranial branches of the external carotid, with vascular remodelling leading to ischemic manifestations such as temporal headaches, jaw claudication, scalp tenderness and visual loss. Most patients with GCA also present signs of systemic inflammation, including weight loss, fatigue and fever, together with an increased erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) level. Glucocorticoids (GC) are the cornerstone of the treatment of GCA. They are very effective and are usually given for 18-24 months to avoid relapses. Therefore, most patients develop GC-related complications that cause morbidity and disability. GC sparing strategies are thus required to improve the treatment of GCA. A 12-month treatment with tocilizumab (TCZ) has recently been shown to be effective in inducing and maintaining remission of GCA, with a dramatic GC-sparing effect. However, TCZ is an expensive drug; TCZ suppresses CRP synthesis and ESR elevation so that it is difficult to monitor patients; and importantly around 40% of patients relapse within 6 months after TCZ discontinuation, whether prescribed for 12 months or 4 months. In association with 6 months of prednisone, 10 mg/week of methotrexate (MTX) for 24 months lowers the risk of relapse at 24 months from 84% to 45%. Therefore, the hypothesis is that 12 months of MTX treatment (0.3 mg/Kg/week, without exceeding 20 mg/week) is not inferior to 12 months of TCZ (162 mg SC/week) in term of prevention of relapse at 18 months. The MTX strategy might be more cost effective than TCZ. In the present study, it is proposed to compare MTX versus TCZ in a multicenter randomized controlled trial. Moreover, the economic consequences associated with the use of MTX rather than TCZ will be also assess.

Exploring Durable Remission With Rituximab in Antineutrophil Cytoplasmic Antibody(ANCA)-Associated...
ANCA Associated VasculitisMost recent insights in the treatment for patients with ANCA-associated vasculitis (AAV) have demonstrated that 'tailored' maintenance treatment with rituximab (RTX) is effective to achieve durable remission of disease. As such, RTX re-treatment can be tailored on the basis of relevant clinical and immunological parameters in AAV patients. Now, the present study intends to evaluate whether combining rituximab with cyclophosphamide is superior to current standard of care with rituximab only to induce a favorable clinical and immunological state in AAV patients and can thereby reduce the number of tailored re-treatments with rituximab.

A Dose Escalation Study Evaluating CPI-818 in Relapsed/Refractory T-Cell Lymphoma
T-cell LymphomaThis is a Phase 1/1b, open-label, first in human study of CPI-818, an oral interleukin-2-inducible tyrosine kinase (ITK) inhibitor for the treatment of relapsed/refractory (R/R) T-cell lymphoma.. This trial will study the safety, tolerability, and anti-tumor activity of CPI-818 as a single drug.

Triple Therapy in T1DM
Type 1 Diabetes MellitusTo assess whether the addition of dapagliflozin to semaglutide and insulin (triple therapy) improves glycemic control in patients with type 1 diabetes compared with semaglutide and insulin (dual therapy) and insulin only (standard) treatment.

Sirolimus in Previously Treated Idiopathic Multicentric Castleman Disease
Castleman DiseaseCastleman's Disease1 moreThe purpose of this study is to understand the impact of sirolimus on idiopathic multicentric Castleman disease.

Intravenous Autologous CD19 CAR-T Cells for R/R B-ALL
Relapsed B Acute Lymphoblastic LeukaemiaRefractory B Acute Lymphoblastic LeukaemiaThis is Phase II / III, Prospective, single arm, Open Label Study to Evaluate Safety and Efficacy of Intravenous Autologous CD19 CAR-T Cells for Relapsed / Refractory B-Acute Lymphoblastic Leukaemia

Eltrombopag vs Standard Front Line Management for Newly Diagnosed Immune Thrombocytopenia (ITP)...
Immune ThrombocytopeniaThis is an investigator initiated, multicenter, open label, randomized phase 3 study for subjects with newly diagnosed ITP from ages 1 to less than 18 years old.

Implementation of STTR Strategies Among People Who Inject Drugs in Malaysia
HIV SeropositivityOpioid-use DisorderThis pragmatic, multisite, implementation and effectiveness research evaluates a strategy to improve HIV treatment outcomes (increased rates of patients on ART with virological suppression, improved treatment retention and ART adherence) for people living with HIV (PLWH) with opioid use disorder (OUD). Engaging 4 large regional HIV/AIDS treatment centers in Malaysia, the study will evaluate barriers and facilitators for implementation of improved care model and will evaluate the comparative effectiveness of the model in a clinical trial. The research will provide critically important evidence for implementation of effective Seek-Test-Treat, and Retain models for PLWH and OUD throughout Malaysia and inform healthcare policy in other low to middle income countries and regions with limited healthcare resources.