View clinical trials related to Lupus Erythematosus, Systemic.
Filter by:This study is an open-label, single-arm, dose escalation and dose expansion study to evaluate the safety, maximum tolerated dose, pharmacokinetic characteristics of allogeneic CD19-CAR-DNT cells (RJMty19) after infusion, and preliminary efficacy in systemic lupus erythematosus (SLE) subjects.
The purpose of the study is to determine the safety, tolerability, and pharmacokinetics of PIT565 in participants with SLE
This is a Phase I study of obecabtagene autoleucel (obe-cel), autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19, to establish the tolerability, safety, preliminary efficacy, and pharmacokinetics of obe-cel in patients with severe, refractory SLE.
Systemic lupus erythematosus (SLE)is an immune-mediated inflammatory disease (IMIDs) of which the cellular and molecular alterations of the immune system driving the diseases still remains largely unknown. Accordingly, it remains difficult to predict the individual patient's response to treatment. Moreover, the patient's response to treatment remains heterogeneous and difficult to predict, despite the development of a variety of novel and powerful drugs (including the so-called biologicals). Therefore, there is a clear need for the identification and validation of cellular and molecular biomarkers which can provide useful clinical information for diagnosis, classification, prognosis and treatment, as well as the development of new therapeutic strategies. Biomarkers can be found and analyzed in different body compartments, of which the peripheral blood and the intra-articular synovial fluid or tissue are most easily accessible. However, previous studies in RA and other IMIDs showed that adaptive immune responses in other tissues such as lymph nodes also play an important role. Investigating other immune compartments of the body such as the lymph nodes could result in new insights. To study the early pathogenesis of inflammatory conditions, in 2008 our department initiated core-needle inguinal lymph node biopsy sampling. Since then more than 100 lymph node biopsy procedures were performed. The procedure is well-tolerated and, other than a small hematoma which does not require therapy in most of the cases, no complications were reported. In the current study, the effects of belimumab (anti-BAFF) in SLE will be investigated by studying the immune alterations taking place in lymph nodes in comparison to peripheral blood and immune alterations taking place in the end-organ, e.g. the joint (wrist, knee or ankle) by taking synovial biopsies during a needle- or mini-arthroscopy. This procedure has been performed frequently in our department over the last 15 years. In this way immune alterations in the lymph nodes (secondary lymphoid organ), peripheral blood (systemic) and the joint (end organ for the disease) will be assessed and compared.
Exploratory clinical study of CNCT19 anti CD19 cell therapy in the treatment of refractory autoimmune diseases,To evaluate the safety and tolerability of CNCT19 in patients with refractory systemic lupus erythematosus (lupus nephritis, immune thrombocytopenia), refractory ANCA-associated vasculitis, and refractory dermatomyositis on the basis of standard of care.
To evaluate the safety and efficacy of CD19-CAR-DNT cells in subjects with relapsed/refractory autoimmune diseases
INTERSTELLAR study will generate critical prospective real-world evidence on the benefits of adding Anifrolumab to standard of care treatment for SLE in routine clinical practice, to inform physicians, payers and patients. The study will use clinical assessments that are relevant for SLE-treating physicians in routine clinical practice, as well as introduce a specific measure for skin manifestations to affirm the potency of anifrolumab in treating SLE-related skin manifestations. The study will use standardized objectives, inclusion/exclusion criteria and outcome measures across all countries participating in this study including GCC (Qatar, KSA), Mexico, CAMCAR (Costa Rica, Panama, Dominican Republic), Colombia, Argentina, Taiwan, and Egypt, and any other countries that may be included in the study, in order to facilitate a comparison and analysis across all countries included in this study.
The goal of this observational study is to investigate if the 2019 EULAR/ACR classification criteria can be used to assess organ damage in patients with systemic lupus erythematosus (SLE) and as predictor for prognosis .
This is an open, Phase I, investigator-initiated study (IIT) to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with moderate or severe active SLE. This study will explore the safety of escalating doses of RD06-04 by presetting two dose levels (DL), with 3 to 6 patients enrolled in each dose level. After safety conclusions are reached in each group, the investigator can select the corresponding dose group to expand cases based on treatment response, but the total number of cases will not exceed 12. This study will enroll patients in a 3+3 design with two DLS: 1×105 CAR+T cells /kg for DL1 and 5×105 CAR+T cells /kg for DL2. Dose increment Refer to the 3+3 dose increment principle. Three subjects are expected to be enrolled in each dose group. 1. Dose increment should start from the minimum dose, and it is not possible to conduct an incremental study of 2 or more dose groups at the same time. 2. If 1 case of DLT occurs in each dose group, the dose level will be extended to 6 subjects. If 6 subjects at this dose level ≥2 subjects develop DLT, the dose level exceeds the MTD. The previous lower dose level will be extended to 6 subjects, and if 6 subjects have already been enrolled in the previous lower dose level, and only ≤1 of these 6 subjects develop DLT, this lower dose level will be considered MTD. 3. If DLT occurred in ≥2 subjects in the highest dose group, the researcher could select a dose between the high dose group and the medium dose group according to the specific situation and perform MTD evaluation. 4. If the dose increase to the highest dose group still does not reach DLT, researchers can explore the safety and efficacy of higher doses according to specific circumstances. Case expansion: After the completion of DLT evaluation in all dose groups, the investigators could select the corresponding dose group of extended cases according to the treatment response, but the total number of cases should not exceed 12 (extended cases were not evaluated by DLT).
This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following conditioning chemotherapy in participants with moderate to severe active systemic lupus erythematosus (SLE). The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT819.