Clinical Research Directory

A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease

This is a single-arm, open-label, multicenter, ascending dose Phase 1 study evaluating the safety and preliminary efficacy of CTX112 in adult subjects with refractory autoimmune diseases, including active systemic lupus erythematosus (SLE), systemic sclerosis (SSc), or idiopathic inflammatory myopathy (IIM).

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus

The goal of this clinical trial is to learn if VENT-03 works to treat patients with cutaneous lupus erythematosus (CLE) who may or may not have systemic lupus erythematosus (SLE). Another goal is to learn about the safety of VENT-03 and how it is processed by the body. The main questions it aims to answer are: * Does VENT-03 affect the activity and severity of CLE? * What side effects do participants have when taking VENT-03? Researchers will compare VENT-03 to a placebo (a look-alike substance that contains no drug) to see if VENT-03 works to treat patients with CLE. Participants will: * Take VENT-03 or a placebo for 4 weeks, then all participants will switch to VENT-03 for another 8 weeks; * Visit the clinic once a month for checkups and tests.

Phase 1a/b Tolerability of NTR-1011 in Healthy Adults and Adult Patients With SLE and RA

The goal of this clinical trial is to inform the safety and tolerability of NTR-1011 in treating adult patients diagnosed with systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA). It will also learn about the safety of NTR-1011 in healthy adult volunteers. The main questions it aims to answer are: * What is the highest dose of NTR-1011 that is safe and well tolerated, when given under the skin or into a vein? * How does the body process NTR-1011, and how does NTR-1011 affect the body? * Does the body develop an immune response to NTR-1011? * Are there early signs that NTR-1011 may benefit patients with SLE or RA when added to their current standard-of-care treatment? In the first part of the study (Phase 1a, now complete), researchers compared single doses of NTR-1011 to a placebo (a look-alike substance that contains no drug) in 48 healthy volunteers to see how the body tolerates and processes the drug. In the current part of the study (Phase 1b, actively recruiting), all participants receive NTR-1011 in addition to their usual SLE or RA treatment; there is no placebo group. Up to 24 participants with moderate-to-severe SLE or RA will: * Receive five weekly doses of NTR-1011 given directly into a vein (intravenous) * Continue their current standard-of-care treatment throughout the study * Be monitored for 4 weeks after their last dose * Be assigned to either the SLE group or the RA group (up to 12 patients each)

A Study in Participants With Mild-to-moderate Systemic Lupus Erythematosus

The main purpose of this study is to evaluate the safety and tolerability of CUG252 following multiple ascending doses in participants with Systemic Lupus Erythematosus (SLE).

A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus

Phase 1b, open-label study of CLN-978 administered subcutaneously in patients with Moderate to Severe Systemic Lupus Erythematosus (SLE).

First-in-Human Study of ISH0613: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics

The goal of this clinical trial is to learn about a study drug called ISH0613 and how it behaves in healthy adults. This study will also evaluate the safety and tolerability of ISH0613 after a single intravenous (IV) dose. The main questions this study aims to answer are: I. What medical problems (side effects) may occur after receiving ISH0613? How does ISH0613 move through and get processed in the body? II. Does ISH0613 affect certain biological markers related to the immune system? III. Researchers will compare ISH0613 to a placebo (a look-alike substance that contains no active drug) to better understand its effects. Participants will: I. Receive a single intravenous infusion of either ISH0613 or placebo II. Stay in the clinical unit for several days for close monitoring after dosing III. Return to the clinic for follow-up visits over several weeks IV. Provide blood samples for safety checks and laboratory testing V. Be monitored for any side effects throughout the study

Clinical Study on Targeted CD19 or CD19-BCMA CAR-T Therapy for Autoimmune Diseases

This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CD19 or CD19-BCMA CAR-T in patients with active SLE, SSc, AAV, IIM and pSS.

A Multi-component, Person-centered, and Yoga-based Coaching Program for Lupus Chronic Pain

This research will assess the feasibility of a tailored yoga coaching program for reducing pain-related symptoms among people with systemic lupus erythematosus.

Efficacy and Safety of CRC01 in Participants With Severe, Refractory Systemic Lupus Erythematosus

The purpose of this clinical trial is to evaluate the safety and efficacy of CRC01, an investigational autologous anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, in people with lupus nephritis (LN), a serious kidney complication of systemic lupus erythematosus (SLE). The main objectives of the study are: 1. To determine whether CRC01 infusion can improve kidney outcomes and reduce disease activity in participants with lupus nephritis. 2. To assess the safety profile, including potential risks such as cytokine release syndrome (CRS) and neurotoxicity. Study Design This is a single-arm, open-label, multi-center, Phase 1/2 study. All enrolled participants will receive CRC01 after screening and baseline assessments. Study Procedures Participants will: * Undergo eligibility screening, including blood tests, urine tests, and disease activity assessments. * Provide autologous T lymphocytes through a procedure called leukapheresis. * Receive a lymphodepleting pre-conditioning regimen (short course of chemotherapy). * Receive a single intravenous infusion of CRC01 cells. * Be hospitalized for close monitoring to detect and manage early adverse events such as CRS or neurotoxicity. * Return for scheduled follow-up assessments through Week 52 (12 months) post-infusion to evaluate safety and treatment response. Key Outcomes Researchers will measure: * Changes in proteinuria and kidney function. * Changes in disease activity scores. * Incidence and severity of adverse events.

Study Evaluating SC291 in Subjects With Severe r/r B-cell Mediated Autoimmune Diseases (GLEAM)

SC291-102 is a Phase 1 study to evaluate SC291 safety and tolerability, preliminary clinical response, cellular kinetics and exploratory assessments for subjects with severe autoimmune diseases.

Efficacy and Safety of Low-dose IL-2 in SLE Patients With CMV Viremia

This clinical trial will assess the efficacy and safety of low-dose interleukin-2 (IL-2) treatment in systemic lupus erythematosus (SLE) complicated with cytomegalovirus (CMV) viremia.

Assessment of CXCL5 Level in SLE Patients and Its Correlation with Disease Activity

Assessment of CXCL5 biomarker in Serum of patients of SLE in comparison to healthy patients and its correlation with disease activity

Safety and Efficacy of CD19 Targeted CAR-T Therapy for Refractory Autoimmune Disease

This is a single arm study to evaluate the efficacy and safety of CD19 targeted CAR-T cells therapy for patients with Refractory Autoimmune Disease

National Systemic Lupus Erythematosus Prospective Cohort, Saudi Arabia

SLE disease in Saudi Arabia is yet not well defined especially in a population with high consanguinity and high inbreeding coefficient . Up until now, there has been no prospective cohort study for SLE patients in Saudi Arabia. As a result, current published literature is focused on retrospective chart reviews which are subjected to many forms of bias. so the investigator proposed this prospective registry which will follow open cohort study design aiming to provide better understanding of disease presentation, course and outcomes especially if complemented by detailed immunological, molecular, genetic and microbiome data.