Clinical trials: Systemic Lupus Erythematosus (Sle)
Lupus Nephritis, Autoimmune Diseases
A Phase 1 Study of Prulacabtagene Leucel (Prula-cel, Formerly ADI-001) in Autoimmune Disease
ADI-202300103 is a phase 1 multicenter, open label, dose finding and dose expansion, safety/efficacy study in patients with autoimmune disease.
- Conditions
- Lupus Nephritis, Autoimmune Diseases, Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT06375993
- Testing
- ADI-001, Fludarabine, Cyclophosphamide
- Where
- 2 sites in United States
- Volunteers
- 180 people
- Sponsor
- Adicet Therapeutics
SLE (Systemic Lupus), Systemic Sclerosis
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…
- Conditions
- SLE (Systemic Lupus), Systemic Sclerosis, ANCA Associated Vasculitis, Idiopathic Inflammatory Myopathies
- Trial name
- NCT06548607
- Testing
- CD19 or CD19-BCMA CAR-T
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.
Systemic Lupus Erythematosus (SLE), Systemic Sclerosis
Exploratory Clinical Study on YTS109 Cell Therapy for Autoimmune Diseases
This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed/refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), including LN and SLE-ITP, Sjogren's Syndrome, etc.
- Conditions
- Systemic Lupus Erythematosus (SLE), Systemic Sclerosis, Sjogren's Syndrome (SS), Inflammatory Myopathy
- Trial name
- NCT07236801
- Testing
- YTS109 cell
- Where
- 2 sites in China
- Volunteers
- 18 people
- Sponsor
- China Immunotech (Beijing) Biotechnology Co., Ltd.
Systemic Lupus Erythematosus (SLE)
A Clinical Study of Dual-Target, Universal CAR-T Cell Therapy for Refractory Systemic Lupus Erythematosus
This study is a single-arm, open-label clinical study designed to evaluate the safety and tolerability of QT-019B in subjects with refractory SLE and to determine the RD.
- Trial name
- NCT07444307
- Testing
- QT-019B Cell Injection
- Where
- 3 sites in China
- Volunteers
- 18 people
- Sponsor
- Hangzhou Qihan Biotech Co., Ltd.
Systemic Lupus Erythematosus (SLE)
Study of YK012 in Moderate to Severe Systemic Lupus Erythematosus
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of YK012 in participants with Moderate to Severe Systemic Lupus Erythematosus (SLE).
- Trial name
- NCT07010835
- Testing
- YK012
- Where
- China
- Volunteers
- 189 people
- Sponsor
- Excyte Biopharma Ltd
Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathies(IIM)
A Study of LUCAR-G79D in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE) and Idiopathic Inflammatory Myopathies (r/r IIM)
This is a prospective, single-arm, open-label and dose-escalation investigator initialed study to evaluate LUCAR-G79D in adult subjects with r/r SLE and r/r IIM.
- Trial name
- NCT07331272
- Testing
- LUCAR-G79D T cells
- Where
- 5 sites in China
- Volunteers
- 38 people
- Sponsor
- Nanjing Legend Biotech Co.
Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
The Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HC022 Injection in Subjects With SLE/CLE
The primary objective of this phase Ib study is to evaluate the safety and tolerability of multiple-ascending, subcutaneous (SC) doses of HC022 in SLE/CLE subjects.
- Trial name
- NCT07306585
- Testing
- HC022
- Where
- China
- Volunteers
- 32 people
- Sponsor
- HC Biopharma Inc.
Lupus Nephritis, Lupus Nephritis (LN)
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…
- Conditions
- Lupus Nephritis, Lupus Nephritis (LN), SLE, SLE (Systemic Lupus)
- Trial name
- CRC01-02 (NCT07364396)
- Testing
- CRC01
- Volunteers
- 39 people
- Sponsor
- Curocell Inc.
Systemic Lupus Erythematosus (SLE), Refractory
Clinical Trial of CD19 Targeted CAR-T Cell in Refractory Adult SLE
This is a single-arm, open, dose-increasing and dose-expanding phase I clinical trial to investigate the safety, tolerability and cytodynamic characteristics of MC-1-50 cell preparation, and to preliminatively observe the…
- Trial name
- NCT06892145
- Testing
- MC-1-50
- Where
- 2 sites in China
- Volunteers
- 12 people
- Sponsor
- Chongqing Precision Biotech Co., Ltd
Neuropsychiatric Systemic Lupus Erythematosus, Systemic Lupus Erythematosus (SLE)
EG-501 for Cognitive Impairment in Neuropsychiatric SLE (NPSLE): Efficacy and Safety Study
Neuropsychiatric systemic lupus erythematosus with cognitive impairment (NPSLE-CI) is a serious, disabling, and potentially life-threatening manifestation of SLE, affecting up to 80% of patients with cognitive impairments ("brain…
- Conditions
- Neuropsychiatric Systemic Lupus Erythematosus, Systemic Lupus Erythematosus (SLE), Cognitive Impairment
- Trial name
- NCT07281105
- Testing
- EG-501
- Where
- 3 sites in United States
- Volunteers
- 131 people
- Sponsor
- Evergreen Therapeutics, Inc.
Lupus Nephritis - WHO Class III, 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 or Other Forms of Refractory Systemic Lupus Erythematosus
AB-101 (also known as AlloNK) is an off-the shelf, allogeneic cell product made of "natural killer" cells, also called NK cells.
- Conditions
- Lupus Nephritis - WHO Class III, Lupus Nephritis - WHO Class IV, Refractory Systemic Lupus Erythematosus, SLE
- Trial name
- NCT06265220
- Testing
- AB-101, Cyclophosphamide, Fludarabine
- Where
- 9 sites in United States
- Volunteers
- 51 people
- Sponsor
- Artiva Biotherapeutics, Inc.
SLE - Systemic Lupus Erythematosus
Allogeneic UCB-derived CAR-T for SLE
The purpose of this clinical trial is to learn if allogeneic, umbilical cord blood-derived chimeric antigen receptor T-cell (UCAR-T) targeting CD19 and BCMA works to treat refractory SLE in adults.
- Trial name
- NCT07274059
- Testing
- allogeneic umbilical cord blood-derived CAR-T targeting CD19 and BCMA
- Where
- 2 sites in China
- Volunteers
- 48 people
- Sponsor
- Chengdu Ucello Biotechnology Co., Ltd.
SLE - Systemic Lupus Erythematosus
CD19/BCMA CAR-T for SLE
The purpose of this clinical trial is to learn if CD19/BCMA CAR-T works to treat refractory SLE in adults. It will also learn about the safety and efficacy of the CD19/BCMA CAR-T cell product.
- Trial name
- NCT07266337
- Testing
- CD19/BCMA CAR T-cells
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Chengdu Ucello Biotechnology Co., Ltd.
SLE - Systemic Lupus Erythematosus
MB-CART19.1 in Refractory SLE
This is a phase l/ll open-label, multicentre, interventional single-arm trial of MB-CART19.1 in patients with refractory SLE systemic lupus erythematosus.
- Trial name
- NCT06189157
- Testing
- MB-CART19.1
- Where
- 3 sites in Germany
- Volunteers
- 29 people
- Sponsor
- Miltenyi Biomedicine GmbH
Systemic Lupus Erythematosus (SLE)
The Purpose of This Study is to Evaluate the Efficacy and Safety of 626 in the Treatment of SLE
This study will evaluate the effect and safety of 626 in patients with SLE
- Trial name
- NCT07185269
- Testing
- 626
- Where
- China
- Volunteers
- 198 people
- Sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Lupus Erythematosus, Systemic Lupus Erythematosus
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.
- Conditions
- Lupus Erythematosus, Systemic Lupus Erythematosus, SLE (Systemic Lupus), Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Trial name
- NCT06294236
- Testing
- SC291
- Where
- 5 sites in United States
- Volunteers
- 7 people
- Sponsor
- Sana Biotechnology
Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathy (IIM)
Safety Study of CC312 in Autoimmune Disease Patients
This study is an open-label, multiple-dose escalation, Investigator-Initiated Trial (IIT) clinical trial designed to evaluate the safety and tolerability of CC312 in adult patients with relapsed and refractory autoimmune…
- Conditions
- Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathy (IIM), Systemic Sclerosis (SSc), Rheumatoid Arthritis (RA)
- Trial name
- NCT06888960
- Testing
- CC312
- Where
- China
- Volunteers
- 18 people
- Sponsor
- CytoCares Inc
SLE - Systemic Lupus Erythematosus
Safety and Efficacy Study of CC312 for Moderate to Severe SLE
This study is a randomized, double-blind, placebo-controlled Phase I clinical trial featuring single and multiple ascending doses.
- Trial name
- NCT07177911
- Testing
- CC312
- Where
- China
- Volunteers
- 32 people
- Sponsor
- CytoCares Inc
Idiopathic Inflammatory Myopathies(IIM), Immune Thrombocytopenia(ITP)
An Exploratory Study of CD19/CD22/BCMA CAR-T Cells (BZE2204) in Subjects With Relapsed or Refractory Autoimmune Diseases
This is a single arm, open-label, dose escalation and expansion study to evaluate the safety, tolerability and preliminary efficacy of autologous chimeric antigen receptor T (CAR-T) cells targeting CD19/CD22/BCMA(BZE2204) in…
- Conditions
- Idiopathic Inflammatory Myopathies(IIM), Immune Thrombocytopenia(ITP), Systemic Lupus Erythematosus(SLE)
- Trial name
- NCT07174843
- Testing
- CD19/CD22/BCMA CAR-T cells(BZE2204)
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shanghai Cell Therapy Group Co.,Ltd
SLE, Lupus
UC-MSC Cell Therapy Study for Systemic Lupus Erythematosus (SLE) Patients
The goal of this clinical trial is to evaluate the safety and effectiveness of UC-MSCs in adults with systemic lupus erythematosus (SLE). The main questions this study aims to answer are: 1.
- Conditions
- SLE, Lupus, Systemic Lupus Erthematosus, Systemic Lupus Erythematosus
- Trial name
- NCT06737380
- Testing
- Physical examination, Electrocardiogram, SF-36 questionnaire
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- LiveKidney.Bio