Active clinical trials for "Immune System Diseases"

Phase III, open-labeled, randomized and multicenter clinical trial to evaluate the superiority of romiplostim plus dexamethasone vs dexamethasone alone in patients with newly diagnosed primary immune thrombocytopenia

Randomized, open-label study to compare the efficacy and safety of prednisone plus recombinant human thrombopoietin (rhTPO) compared to prednisone monotherapy for the treatment of immune thrombocytopenia in pregnancy

Background: Shiners are caused when blood and other fluids accumulate in the infraorbital groove. It develops resulting from lots of problems. In patient with rhinitis, either allergic rhinitis or non-allergic rhinitis, shiners are believed to be caused by venous stasis resulting from nasal congestion. This study is aiming that comparison of the effectiveness of treatment of rhinitis (either allergic rhinitis or non-allergic rhinitis) to lighten not only the rhinitis but also the shiners. Randomized control studies. Design: The investigators will recruit children (6-12 y/0), adolescent (13-18 y/o), or adults (19-65 y/o) with either allergic rhinitis or non-allergic rhinitis, and patients will be randomly assigned to groups (oral antihistamine, combined nasal corticosteroids with oral antihistamine, combined nasal corticosteroids with oral antihistamine plus nasal decongestant, combined nasal corticosteroids with oral antihistamine plus nasal irrigation, combined oral antihistamine with nasal irrigation, or nasal antihistamine only). Digital image will be recorded and analyzed to compare the change of shiners between before and after treatment for rhinitis. The clinical data were collected including patient's data, history, laboratory data, Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ), Adolescent Rhinoconjunctivitis Quality of Life Questionnaire (AdolRQLQ), or mini Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ), and medications. The primary outcome is to answer whether the levels of shiners can be alleviated by using therapies in patient with rhinitis. And the secondary outcome is to figure out which therapies work most effectively. Keywords: allergic rhinitis, vasomotor rhinitis, shiners, nasal corticosteroids

This study is a single-arm, open-label, multicenter, dose-escalation clinical study.Its primary purpose is to evaluate the safety and tolerability of recombinant humanized anti-interleukin-6 receptor monoclonal antibody ( Anti-IL-6R mAb ) injection in patients with Idiopathic Multicentric Castleman's Disease ( iMCD ) and to determine the recommended dose for follow-up studies. Its secondary purpose is to evaluate the preliminary efficacy, immunogenicity and pharmacokinetic ( PK ) index, pharmacodynamic ( PD ) characteristics of Anti-IL-6R mAb injection in patients with iMCD.

Rationale: Clemastine fumarate has been identified as potential remyelinating therapy for multiple sclerosis (MS). The (long-term) effects of clemastine need to be confirmed in clinical models for MS. Internuclear ophthalmoparesis (INO) may be used as a clinical model for investigating remyelinating therapies by measuring horizontal eye movements with infrared oculography. Furthermore, infrared oculography combined with a single dose of fampridine may be used to identify individuals with MS that are most likely to benefit from remyelinating therapy. Objective: To assess the (long-term) efficacy of clemastine fumarate in improving dysconjugacy of eye movements in patients with internuclear ophthalmoparesis and multiple sclerosis. Secondly, to assess whether a response to a single dose of fampridine can predict the effects of clemastine treatment. Study design: A single-centre double-blind randomized placebo-controlled trial consisting of a 6 months (180 days) treatment period followed by a 30 months follow-up period. Study population: 80 MS patients, age 18-70 years, with INO. Intervention: The intervention group will receive 4 mg of clemastine fumarate twice daily (8 mg/day) for 6 months (180 days), the control group will receive an equivalent amount of placebo. At baseline all participants will receive a single 10 mg dose of fampridine. Main study parameters/endpoints: The primary outcome measure is the change in versional dysconjugacy index (VDI) of area under the curve (AUC) measured by infrared oculography. Secondary outcome measures include changes in other VDI measures (peak velocity per amplitude (PV/Am) and peak velocity (PV)), changes in VDI after single fampridine dose, other oculography parameters (e.g. saccadic latency, anti-saccades), (peripheral) retinal nerve fibre layer (pRNFL) and (macular) ganglion cell inner plexiform layer (mGCIPL) thickness measured by OCT, SDMT, EDSS, high and low contrast visual acuity, subjective visual functioning (NEI-VFQ-25 and NOV-AU questionnaire), quality of life (EQ5D-5L) and fatigue (CIS20R and NFI-MS questionnaire). Nature and extent of the burden and risks: Participation in the study will consist of a total of 7 study visits. Study visits will include physical/neurological examination, infrared oculography, OCT, visual acuity tests, a cognition test (SDMT), 5 questionnaires and blood samples for safety laboratory tests. Considering both clemastine and fampridine are registered and well-established drugs and have been used in clinical practice, the estimated risk of unexpected adverse reactions is low.

Recently, robotic-assisted thoracic surgery (RATS) has become into as an alternative approach to either, open surgery or video-assisted thoracoscopic surgery. The superiorities of RATS have been reported in series studies, such as intuitive movements, tremor filtration, more degrees of manipulative freedom, motion scaling, and high-definition stereoscopic vision. However, the currently reported robotic thymectomy used 3 ports. Theoretically, less incisions may bring faster postoperative recovery, lighter postoperative pain and higher postoperative quality of life. The investigators have successfully performed robotic thymectomy through 2 ports and even 1 port. However, the potential benefit of less ports robotic thymectomy has not been verified through well-designed cohort study, so this clinical trial has been designed.

The purpose of this research study is to test if a combination treatment of chimeric antigen receptor (CAR) T-cell therapy, Mosunetuzumab, and Polatuzumab Vedotin will result in tumor reduction.

This study is a continuation of a clinical trial NCT044155930 comparing the efficacy and safety of oral immunotherapy (OIT) with low or high doses of peanut protein (150 or 300 mg, respectively) and will involve patients who have accomplished their per-protocol participation in that trial. The aim of current study is to assess a sustained unresponsiveness (SU) to allergen protein after at least 8 months of previously assigned high- or low-dose peanut OIT, followed by 4-week-allergen avoidance, and verified by an open oral food challenge (OOFC).

CD19 CAR-T has been widely developed in patients with R/R ALL and has also been generally recognized by the industry. In 2017, the U.S. FDA approved Novartis's CD 19 CAR-T product Kymriah for the treatment of R/R ALL. However, these CAR-T cells are constructed from patients' autologous T cells, and the production and preparation time is long; on the other hand, most patients have received multiple chemotherapy before CAR-T treatment, and the quantity and quality of T cells often cannot meet the needs of clinical treatment. It is also an important factor leading to the failure of CAR-T cell therapy, which limits the large-scale clinical application of CAR-T. T cells derived from healthy donors are not only sufficient in quantity and quality guaranteed, but also available at any time. In December 2020, lancet reported a clinical study of 19 patients receiving allogeneic CAR-T cell ALL. 14 patients were evaluated as CR/CRi (67%) 28 days after treatment, and the median sustained remission time was 4.1 moon. Allogeneic CAR-T cells are safe and effective for the treatment of ALL, and their clinical application range is expected to improve the remission rate and survival rate of patients with R/R ALL.

This multi-center center phase I/II study to establish the lowest possible recommended phase 2 dose (RP2D) of corticosteroids in conjunction with ruxolitinib and uhCG/EGF (a novel combination) for high-risk aGVHD. This is a single arm study designed to determine the lowest dose of corticosteroids required (toxicity endpoint) without impairing GVHD complete response or partial response (CR/PR) at day 28 when given in conjunction with uhCG/EGF and ruxolitinib. After completion of the corticosteroid dose finding, the final dose will be carried forward into a two-stage phase II extension trial to confirm safety and make a preliminary determination of efficacy of this novel drug combination for high-risk aGVHD.