Active clinical trials for "Immune System Diseases"

Primary Objective: To evaluate the efficacy of treatment with dupilumab to reduce sinus opacification in a population with allergic fungal rhinosinusitis (AFRS) Secondary Objectives: To evaluate the efficacy of treatment with dupilumab to reduce sinus opacification in a population with allergic fungal rhinosinusitis (AFRS) at Week 24 To assess the efficacy of dupilumab to reduce the need for rescue treatments To evaluate the efficacy of treatment with dupilumab in improving symptoms in AFRS To evaluate the efficacy of dupilumab to reduce nasal polyp formation in participants with AFRS To evaluate the efficacy of dupilumab in improving overall symptom severity and quality of life in AFRS To evaluate the efficacy of dupilumab in improving sense of smell in participants with AFRS To explore the effect of dupilumab as assessed by three-Dimensional CT volumetric measurement of the paranasal sinuses To evaluate the safety and tolerability of dupilumab when administered to participants with AFRS To evaluate the pharmacokinetics (PK) of dupilumab in participants with AFRS To characterize the effect of dupilumab on total IgE and specific IgE To assess immunogenicity to dupilumab in participants with AFRS

The purpose of this study is to find the maximum dose of huCART19-IL18 cells that is safe for use in humans with CD19+ cancers.

RADAR is a multicentre, international, randomised, open-label phase III clinical trial composed of 2 trials running in parallel. Trial 1 will be led and sponsored by University College London (UCL) and conducted in Europe and Australia/New Zealand. Trial 2 will be led by the Canadian Cancer Trials Group (CCTG) and conducted in North America, with CCTG the regulatory sponsor in Canada, and University of Miami the regulatory sponsor and IND holder in the US. Datasets from Trial 1 and Trial 2 will be combined to achieve the total sample size. Data analysis will be performed by UCL and therefore UCL is responsible for the clinicaltrials.gov entry. Eligible patients will be randomised to receive either ABVD or A2VD chemotherapy. An interim PET-CT scan will be performed after 2 cycles of treatment, which will be used to adapt subsequent treatment. Patients will receive a total of 3-4 cycles of chemotherapy and may also receive involved site radiotherapy as consolidation. Patients will be followed up for a minimum of 5 years after treatment.

This is a multi-centers, single-arm, open label, Phase 2 clinical trial to evaluate the efficacy and safety of CD7 CAR T cells in subjects with relapsed or refractory T-cell leukemia/lymphoma. Seventy subjects will be enrolled. CD7 CAR T cells will be given once intravenously at one dose (1×106, with an allowance of ± 20%) in patients received previous HSCT donor-derived CAR T cells. Patients who received fresh donor derived CD7 CAR T cells were given initial dose of 1×106, with an allowance of ± 20%. The dose levels may be adjusted during the study based on the specific number of cells on the day of fresh CAR T cells infusion, due to at this time all the patients have completed lymphodepleting, so we adopt the allowance of ±20% for each group of absolute infusion cells. And patients who were lower than the designed dose group were also given infusion, but they will be either assigned to the lower dose group or exclude from safety analysis of designed dose group.

Acute intestinal GVHD is the main cause of death after allo-HSCT, and FMT is a new treatment method for this disease. In this prospective study, the investigators will recruit intestinal GVHD patients to demonstrate the efficacy and safety of FMT.

This study will evaluate the efficacy and safety of mosunetuzumab in combination with lenalidomide (M + Len) compared to rituximab in combination with lenalidomide (R + Len) in participants with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least one line of prior systemic therapy.

HSP-CAR30 is a cell suspension of genetically modified T-cells to express a second generation (4-1BBz) chimeric antigen receptor (CAR) directed against CD30. This is a phase I/IIa, interventional, single arm, open label, treatment study to evaluate the safety, tolerability and efficacy of HSP-CAR30 in patients with relapsed/refractory Hodgkin lymphoma and relapsed/refractory T-cell lymphoma expressing CD30.

This is a single arm study to evaluate the efficacy and safety of CD19 and CD22 targeted CAR-T cells therapy for patients with relapsed/refractory B Cell Leukemia and Lymphoma.

Toxic epidermal necrolysis (TEN) including Stevens Johnson (SJS) and Lyell syndromes represent the most severe drug eruptions. It is an allergic disorder caused by cytotoxic T lymphocytes, specific of drugs, responsible for the destruction of keratinocytes by apoptosis. Regulatory T cell (CD25 high CD4+), normally responsible for controlling the activation of cytotoxic T lymphocytes, have altered function. Despite the progress made in the pathophysiological understanding of TEN, there is currently no effective treatment. The main symptom is bullous and skin peeling > 10% giving the appearance of great burns. The death rate is estimated between 30 and 40% due to visceral inflammatory injuries and bacterial superinfection. The risk of mortality is estimated during the initial treatment by calculating the SCORTEN (mortality>10% if SCORTEN>2, mortality>90% if SCORTEN>5). The morbidity is also very important (92% at 1 year), especially ophthalmologic with high risk of blindness... The therapeutic potential of G-CSF (Granulocyte-Colony Stimulating Factor) in TEN is supported by several observations. The G-CSF promotes skin healing. This has been shown in human burns, with a significant reduction in healing time under G-CSF. The mechanisms associate the growth factor effect on keratinocytes, macrophages stimulation and metalloprotease activity allowing tissue remodeling limiting sequels onset. Otherwise, healing altered in deficient G-CSF mice is corrected by the growth factor injection. The G-CSF is an immunomodulator whose activities appear to justify use in TEN : Polarization of immune response to Th2 non-cytotoxic (anti Th1), Preferential differentiation of naive LT (T lymphocytes) in regulator LT (CD25 high CD4+) and mobilization of regulator LT of the spinal cord to altered tissues. The G-CSF was used in a few cases of TEN with great efficacy. No data is available concerning sequels of SJS/TEN in treated patients. This clinical trial program, by providing proof of the efficacy of filgrastim in SJS/TEN, should allow progress in care of this serious toxics diseases. In the future, it could thus reduce the significant morbidity of these syndromes with a high rate of sequelae.

Even though glucocorticoid is the current first line medication for IgG4-RD, it is well accepted in the field that excessive dosage of GC, especially accumulative dosage, is associated with increasing organ damage. Although B cell depletion with rituximab has been verified to be an effective treatment for IgG4-RD, even without concomitant GC therapy, rituximab can increase the risk of infection during the treatment. Belimumab is an IgG1-lambda monoclonal antibody that prevents the survival of B lymphocytes by blocking the binding of soluble human B lymphocyte stimulator protein (BLyS) to receptors on B lymphocytes. Previous studies and trails suggested that the activity of B-cell mediated immunity and autoimmune responses were ameliorated after belimumab without increasing rates of adverse events when compared to standard of care . However, the efficacy and tolerability of belimumab in IgG4-RD patients have not been examined before. This randomized, control clinical trial aimed to evaluate the tolerability and the efficacy of Belimumab for maintenance treatment for IgG4-RD.