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Showing 1-20 of 106 trials
NCT07053800
The purpose of this trial is to evaluate the efficacy and safety of obecabtagene autoleucel (obe-cel) administered once following lymphodepletion in participants with severe, refractory systemic lupus erythematosus (SLE) and active lupus nephritis (LN).
NCT06308978
This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in participants with moderate-to-severe active systemic lupus erythematosus (SLE) with or without nephritis, antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc). The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT819.
NCT07570862
The primary objective of this trial is to evaluate the efficacy and safety of FT819, comprised of allogeneic T cells that express a CD19-targeted CAR, following bendamustine administration in participants with refractory moderate-to-severe lupus nephritis, as assessed by the proportion of participants who achieve complete renal response (CRR) at Week 26.
NCT04221477
This study will evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab compared with placebo in participants with International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 class III or IV lupus nephritis (LN) when added on to standard-of-care therapy consisting of mycophenolate mofetil (MMF) and corticosteroids.
NCT06434363
The goal of Safety Lead-In is to confirm the safety of tafasitamab when given to patients with SSc, SLE, and LN. The goal of Phase 1 is to find the recommended dose of AD-PluReceptor-NK cells in combination with tafasitamab and lymphodepleting chemotherapy that can be given to patients with the disease. The goal of Phase 2 is to learn if the dose of AD-PluReceptor-NK cells found in Phase 1 in combination with tafasitamab and lymphodepleting chemotherapy can help to control the disease.
NCT06375993
ADI-202300103 is a phase 1 multicenter, open label, dose finding and dose expansion, safety/efficacy study in patients with autoimmune disease. The study will consist of different periods including screening, lymphodepletion, treatment, and follow-up
NCT05126277
This trial will evaluate efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN
NCT05538208
The study is a 1-year 2-part double-blinded placebo controlled 2-arm clinical trial. Treatment arms are (1) MMF dosed as per body-surface area (MMFBSA; 600mg/m2 body surface area per dose about every 12 hours) and (2) pharmacokinetically-guided precision-dosing of MMF (MMFPK; MMF dosed twice daily to achieve an area under the concentration-time curve (AUC0-12h) of MPA \>60-70 mg\*h/L. The study goal is to determine the safety and efficacy of MMFPK compared to MMFBSA for the treatment of proliferative LN in subjects 8 to \<21 years.
NCT07015983
The purpose of this study is to evaluate the efficacy, safety and drug levels of CC-97540 in participants with active systemic lupus erythematosus (SLE) including lupus nephritis with inadequate response to glucocorticoids and at least 2 immunosuppressants.
NCT06947460
This is a single-center, open-label, non-randomized, single-arm clinical trial. Patients with refractory lupus neritis (SLE-LN), systemic sclerosis (SSc), and primary Sjogren syndrome combined with pulmonary artery hypertension (pSS-PAH) receive CD19-BCMA CAR T cell therapy. The primary objective is to prospectively assess the safety of CD19-BCMA CAR T cell therapy in patients with SLE-LN, SSc, and pSS-PAH. The primary endpoint is the type and incidence of dose-limiting toxicity (DLT) within 28 days after CD19-BCMA CAR T cell infusion.
NCT04883619
The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active Lupus Nephritis (LN).
NCT06839976
This is a single-center, single-arm, open-label phase 1/2 study of CART19 in children and young adults with refractory Systemic lupus erythematosus (SLE), including both patients diagnosed with lupus nephritis (LN) and patients with non-renal Systemic lupus erythematosus (SLE). Phase 1 will evaluate the safety of CART19 in 6-12 patients with Systemic lupus erythematosus (SLE). There is no planned dose escalation, but a dose de-escalation will be made based on the incidence of Dose Limiting Toxicities. Phase 2 will evaluate the efficacy and further evaluate the safety of CART19 in this population.
NCT05288855
The purpose of this study is to assess the efficacy and safety of voclosporin compared to placebo in achieving renal response following 24 weeks of therapy in adolescent and pediatric subjects with active lupus nephritis (LN).
NCT07323524
Lupus nephritis is a chronic and life-threatening autoimmune cause of kidney disease that predominately impacts young people and can lead to kidney failure. Sodium-glucose co-transporter-2 inhibitors, including dapagliflozin, are known to improve outcomes for people with other causes of chronic kidney disease. This pilot and feasibility randomized clinical trial will test the use of dapagliflozin versus placebo in addition to standard of care treatment for patients with early and active lupus nephritis, a group who has not been included in past trials.
NCT06935474
This multi-center, open-label, Phase 1/2 study aims to evaluate the safety, tolerability, and preliminary efficacy of C-CAR168, an autologous anti-CD20/BCMA CAR-T therapy, in patients with autoimmune diseases refractory to standard treatments. The study includes both dose escalation and dose expansion phases, with participants grouped into condition-specific cohorts. The purpose of this study is to: 1. Test the safety and ability for subjects with autoimmune refractory to standard treatment to tolerate the C-CAR168. 2. Determine the recommended Phase 2 dose of C-CAR168 in subjects with autoimmune disease refractory to standard treatment. Participants will be asked to: * Undergo screening to determine eligibility based on entry criteria. * Taper steroid use before leukapheresis. * Undergo leukapheresis for the manufacturing of C-CAR168. * Temporarily discontinue immunosuppressive therapy at least 7 days prior to leukapheresis. * Receive bridging therapy (steroids) if necessary to maintain disease stability during C-CAR168 manufacturing. * Undergo lymphodepletion therapy with fludarabine and cyclophosphamide. * Receive a single intravenous infusion of C-CAR168 at the assigned dose level on Day 0. * Attend regular safety and efficacy assessments for up to 24 months post-infusion. * Undergo dose-limiting toxicity evaluation during the first 28 days post-infusion (for those in the dose escalation phase). * Follow withdrawal procedures if necessary, including a discharge visit within 14 days if their condition deteriorates, unacceptable toxicity occurs, they no longer meet criteria, or they choose to withdraw.
NCT07031674
The objective of this observational study is to compare the efficacy and safety of telitacicept and belimumab in the treatment of lupus nephritis in patients aged 18-65 years with lupus nephritis. The main question it aims to answer is: What are the response rates of the two drugs for the main renal therapy in the lupus nephritis population? Which drug has better efficacy and safety? This study is a retrospective study. The participants will not receive any treatment.
NCT07109986
This is an open-label investigator-initiated trial (IIT) to assess the safety, efficacy, and PK（pharmacokinetic）/PD（pharmacodynamics ） of UB-VV410 in adult subjects with clinically active treatment-refractory SLE. The study population will include subjects with active LN (as defined by evidence of active inflammation on renal biopsy, referred to as the LN cohort) and subjects with active SLE without LN (ie, non-LN SLE, referred to as the non-LN cohort). It is expected that the safety profile of UB-VV410 will be similar in subjects with active LN and subjects with active non-LN SLE; thus, dose finding (DF) will be conducted in the 2 subpopulation cohorts combined. Dose expansion (DE) may be conducted separately in the LN and non-LN cohorts to characterize the preliminary efficacy of UB-VV410, as well as its safety and PK/PD, in each subpopulation. The objective of this study is to determine the MTD（maximum tolerated dose）/MAD（maximum administered dose） and the recommended dose for subsequent studies of UB-VV410 in subjects with active LN and in subjects with active non-LN SLE. The DF portion will evaluate the safety profile of UB-VV410 administered at various DLs（dose levels）. The DE portion will further optimize the dose and define the safety profile and preliminary efficacy of UB VV410. The study will use the Bayesian optimal interval (BOIN) design to allocate subjects to various DLs to minimize exposure to subtherapeutic DLs while maintaining appropriate safety parameters. DF will be initiated with UB-VV410 administered IV and starting at DL1. During DF, additional subjects may be backfilled at DLs found to be safe per the BOIN design and with promising activity. After DF of UB-VV410 has been completed, DE with up to 14 subjects per DL within each subpopulation cohort (eg, LN and non-LN cohorts) may be implemented at DLs less than or equal to the MTD/MAD and demonstrating efficacy to further characterize the toxicity, tolerability, PK/PD, and preliminary efficacy of UB-VV410 at the selected DLs. The DE portion will further characterize product safety and preliminary efficacy in order to optimize benefit/risk. The number of DLs for DE will be determined based on the safety, activity and PK/PD data observed from DF. In addition, some subjects may receive retreatment with UB-VV410 if there are preliminary findings suggesting incomplete improvement and acceptable safety.
NCT06927219
Summary The Lupus Foundation of America (LFA) Research Accelerated by You (RAY) Registry is a fully remote, longitudinal registry designed to collect data from adults and children living with lupus. The primary goal is to better understand the diagnosis, treatment, care, and quality of life for those affected by the disease. Remote Participation This is a decentralized, online-only registry. Participation is conducted entirely through a secure web-based portal. There are no physical site visits or travel requirements; participants can contribute from any location with internet access. Participation Details Consent: Informed consent is completed electronically. Surveys: Participants complete electronic surveys upon enrollment and every six months thereafter. Data Types: Collected data is self-reported and includes demographics, diagnosis history, treatment information, and patient-reported outcomes (PROs), such as quality of life. Purpose and Data Use The LFA uses registry data to: Address Constituent Needs: Inform programs and resources for the lupus community. Advance Research: Share patient insights with to ensure therapies are developed with the consideration of what matters and what matters most to people living with lupus. Patient Engagement and Clinical Research Matching: Participants may be contacted to assess eligibility for patient engagement or clinical research opportunities or to complete specific sub-surveys regarding trial participation.
NCT06564181
The goal of this observational study is to investigate the relation between serum zinc and lupus nephritis by search Prevalence of hypozincemia in lupus nephritis and Association between serum zinc and urea, serum creatinine, hemoglobin, estimated glomerular filtration rate (eGFR).
NCT05810948
The purpose of the study is to evaluate the efficacy and safety of efgartigimod IV in Chinese patients with active lupus nephritis (LN). The study comprises an approximate 4-week screening period, a 24-week treatment period, and an 8-week follow- up period.