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Nephritis clinical trials

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NCT ID: NCT06342960 Recruiting - Lupus Nephritis Clinical Trials

A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis (KYSA-3)

Start date: December 1, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy for Subjects With Refractory Lupus Nephritis

NCT ID: NCT06285279 Recruiting - Lupus Nephritis Clinical Trials

FKC288 in Participants With Autoimmune Kidney Diseases

Start date: March 4, 2024
Phase: Phase 1
Study type: Interventional

This study is a single-center, open-label, dose-escalation exploratory clinical trial, expected to enroll 6 to 12 participants. It will use a BOIN (Bayesian Optimal Interval) design for dose escalation, with four predetermined dose groups (0.3×10^6 cells/kg, 1.0×10^6 cells/kg, 3.0×10^6 cells/kg, and an alternative dose of 0.1×10^6 cells/kg). Each dose group plans to enroll 1-2 or 3-6 participants with relapsed or refractory autoimmune-mediated kidney diseases (such as lupus nephritis, ANCA-associated vasculitis, membranous nephropathy, and IgG4-related diseases).

NCT ID: NCT06277427 Recruiting - Lupus Nephritis Clinical Trials

Refractory ANCA Associated Vasculitis and Lupus Nephritis Treated With BCMA-targeting CAR-T Cells

Start date: February 5, 2024
Phase: N/A
Study type: Interventional

Lupus nephritis (LN) and ANCA-associated vasculitis are severe autoimmune diseases, which may lead to the death of patients, particularly when they are refractory to the conventional therapeutic agents. Based on the current knowledge, the autoantibodies against self-antigens may exert important pathological roles in the pathogenesis of both LN and ANCA-associated vasculitis, of which the origins are primarily plasmablasts and plasma cells. BCMA is the molecule expressed on memory B cells, plasmablasts and plasma cells, and therefore is an ideal target for the elimination of potential pathogenic antibody secreting cells. Chimeric antigen receptor (CAR) T cells against BCMA may provide a novel therapeutic way for the refractory LN and ANCA-associated vasculitis patients to eliminate the pathogenic autoantibody-secreting cells. In this study, the safety and efficacy of a novel CAR-T cell therapy using PRG-1801 cells, are evaluated in patients with refractory LN and ANCA-associated vasculitis.

NCT ID: NCT06265220 Recruiting - Clinical trials for Lupus Nephritis - WHO Class IV

AB-101 in Combination With B-Cell Depleting mAb in Patients Who Failed Treatment for Class III or IV Lupus Nephritis

Start date: February 24, 2024
Phase: Phase 1
Study type: Interventional

AB-101 (also known as AlloNK) is an off-the shelf, allogeneic cell product made of "natural killer" cells, also called NK cells. White blood cells are part of the immune system and NK cells are a type of white blood cell that is known to enhance the effect of monoclonal antibody therapies. This clinical trial will enroll adult patients with lupus nephritis Class III or IV either with or without the presence of Class V who relapsed or did not respond to previous standard of care treatment approaches. The primary objective is to assess the safety, tolerability and preliminary activity of AB-101 plus rituximab after cyclophosphamide and fludarabine in adult subjects with relapsed/refractory lupus nephritis Class III or IV, with or without the presence of Class V. Patients will be assigned to receive either AB-101 alone as monotherapy or in combination with rituximab. All patients will receive at least 1 treatment cycle of AB-101, followed by scheduled assessments of overall health and response status. Patients may receive up to 2 cycles of treatment spaced 24 weeks apart.

NCT ID: NCT06167174 Recruiting - Lupus Nephritis Clinical Trials

Exploring Biomarkers for Therapeutic Response of Lupus Nephritis Based on Multi Omics Analysis

Start date: December 5, 2023
Phase:
Study type: Observational

This is an observational study of patients with lupus nephritis aiming to find biomarkers that can predict patients' response to immunosuppressants. We planed to collect 100 lupus nephritis patients' peripheral blood,kidney tissues and urine before and after treatment (mycophenolate mofetil or cyclophosphamide, in combination with glucocorticoids). Then multi omics analysis, including single cell RNA-seq, ATAC-seq and CITE-seq, will be performed to find new biomarkers for patients' response and prognosis.

NCT ID: NCT06153095 Recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study of IMPT-514 in Active Refractory Systemic Lupus Erythematosus (SLE)

Start date: February 15, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2, multi-center, open-label study evaluating the safety and efficacy of IMPT-514, a bispecific chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in participants with active, refractory lupus nephritis and systemic lupus erythematosus. IMPT-514 treatment consists of a single infusion of CAR-transduced autologous T cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide. Individual participants will remain in the active post-treatment period for approximately 1 year. Participants will continue in long-term follow-up for 15 years from treatment.

NCT ID: NCT06121297 Recruiting - Clinical trials for Systemic Lupus Erythematosus

RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus

Start date: February 16, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus

NCT ID: NCT06064929 Recruiting - Lupus Nephritis Clinical Trials

A Study of Felzartamab in Participants With Lupus Nephritis

Start date: November 1, 2023
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to evaluate the safety and tolerability of felzartamab plus standard of care in participants with refractory Lupus Nephritis (LN).

NCT ID: NCT06058078 Recruiting - Lupus Nephritis Clinical Trials

RY_SW01 Cell Injection Therapy in Active Lupus Nephritis

Start date: August 17, 2023
Phase: Phase 2
Study type: Interventional

RY_SW01 Cell Injection's preclinical research results have shown that the injection significantly improved urine biochemical indicators and tissue damage in two lupus nephritis animal models after MSC administration, with no occurrence of rejection and excellent safety. The mechanism of action of RY_SW01 Cell Injection is relatively clear, demonstrating favorable therapeutic effects in preclinical animal models. Compared to existing conventional therapies, it has the advantages of "convenient treatment and sustained efficacy." It may help reduce the variety and quantity of drugs administered to patients and the various side effects associated with drug treatment. In some cases, it may even lead to the discontinuation of immunosuppressive drugs, reducing mortality and disability rates while improving the quality of life for patients. Its unique advantages have the potential to fundamentally change the current clinical treatment landscape and offer promising prospects for clinical application.

NCT ID: NCT05938725 Recruiting - Lupus Nephritis Clinical Trials

A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis

Start date: April 28, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy for Subjects With Refractory Lupus Nephritis