Clinical trials: REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS
Lupus Erythematosis
F01 in the Treatment of Moderate-to-severe Refractory Systemic Lupus Erythematosus
This is a phase I clinical study to evaluate the safety , pharmacokinetic profile, and preliminary efficacy of F01 in patients with moderate-to-severe refractory systemic lupus erythematosus.
- Trial name
- NCT06468683
- Testing
- After preconditioning with chemotherapy, F01 will be evaluated.
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Shanghai Simnova Biotechnology Co.,Ltd.
Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies
Preliminary Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases
To evaluate the safety of UTAA09 injection in the treatment of relapsed/refractory (R/R) autoimmune disease (AID). To evaluate the pharmacokinetic (PK) profile of UTAA09 injection in patients with R/R AID.
- Conditions
- Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies, Systemic Sclerosis, Sjogren's Syndrome
- Trial name
- NCT06417398
- Testing
- T cell injection targeting CD19 chimeric antigen receptor
- Volunteers
- 10 people
- Sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Lupus Erythematosus, Systemic, Lupus Nephritis
A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)
The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel (administered once following lymphodepletion) in patients with active, refractory systemic lupus erythematosus (SLE) or active…
- Trial name
- NCT06581198
- Testing
- rapcabtagene autoleucel
- Where
- 107 sites in United States, Argentina and 24 more
- Volunteers
- 179 people
- Sponsor
- Novartis Pharmaceuticals
Systemic Lupus Erythematosus, Lupus Nephritis
A Study of IMPT-514 in Active Refractory Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE)
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…
- Trial name
- NCT06153095
- Testing
- IMPT-514
- Where
- 4 sites in United States, Australia
- Sponsor
- Lyell Immunopharma, Inc.
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, Sjögren's Disease
A Study of BMS-986553 in Participants With Refractory Autoimmune Diseases
The purpose of this study is to evaluate the safety and tolerability of BMS-986553, CD19 in vivo Chimeric Antigen Receptor (CAR) T cells, in participants with refractory autoimmune diseases including systemic lupus erythematosus…
- Conditions
- Systemic Lupus Erythematosus, Sjögren's Disease, Rheumatoid Arthritis, Idiopathic Inflammatory Myopathies
- Trial name
- NCT07873931
- Testing
- BMS-986553
- Where
- 23 sites in United States, Belgium and 4 more
- Volunteers
- 60 people
- Sponsor
- Bristol-Myers Squibb
Systemic Lupus Erythematosus, Active Refractory Rheumatoid Arthritis
A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases
The main objective is to assess the safety and tolerability of inebilizumab in adult participants with active and refractory systemic lupus erythematosus (SLE) with nephritis (Subprotocol A) and to assess the safety and…
- Trial name
- NCT06570798
- Testing
- Inebilizumab, Blinatumomab
- Where
- 58 sites in United States, Australia and 8 more
- Volunteers
- 220 people
- Sponsor
- Amgen
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), Lupus Nephritis (LN)
A Phase IIa Study of ICG318 CAR-T in Refractory Systemic Lupus Erythematosus With or Without Lupus Nephritis
This Phase IIa, open-label, single-arm study includes an initial Safety Run-In followed by dose expansion to evaluate the safety, tolerability, cellular kinetics, pharmacodynamics, and preliminary clinical activity of a single…
- Trial name
- NCT07328581
- Testing
- ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T following lymphodepletion
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- iCell Gene Therapeutics
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
Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
A Clinical Study of YTS109 Cell for R/R 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), Lupus Nephritis (LN), Systemic Sclerosis (SSc), Inflammatory Myopathy
- Trial name
- NCT07104721
- Testing
- YTS109 cell
- Where
- China
- Volunteers
- 18 people
- Sponsor
- China Immunotech (Beijing) Biotechnology Co., Ltd.
Systemic Lupus Erythematosus, Systemic Sclerosis
An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease
An exploratory clinical study of the safety and efficacy of YTS109 cell injection in subjects with recurrent/refractory autoimmune disease
- Conditions
- Systemic Lupus Erythematosus, Systemic Sclerosis, Inflammatory Myopathy, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Trial name
- NCT06379646
- Testing
- YTS109
- Where
- China
- Volunteers
- 6 people
- Sponsor
- China Immunotech (Beijing) Biotechnology Co., Ltd.
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.
Systemic Lupus Erythematosus, Lupus Nephritis (LN)
An Exploratory Clinical Study of YTS109 Cell for R/R 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, Lupus Nephritis (LN), Sjogren's Syndrome, Inflammatory Myopathy
- Trial name
- NCT07236762
- Testing
- YTS109 cell
- Where
- China
- Volunteers
- 18 people
- Sponsor
- China Immunotech (Beijing) Biotechnology Co., Ltd.
Rheumatoid Arthritis (RA), Systemic Lupus Erthematosus (SLE)
BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Autoimmune Disease
Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory autoimmune disease, however not all disease responds or remains in response to CD19 targeted CAR-T cells.
- Conditions
- Rheumatoid Arthritis (RA), Systemic Lupus Erthematosus (SLE), Dermatomyositis (DM), Systemic Sclerosis (SSc)
- Trial name
- NCT07729995
- Testing
- LMY-922
- Where
- United States
- Volunteers
- 94 people
- Sponsor
- Luminary Therapeutics
SLE (Systemic Lupus), Sjogren's Syndrome
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
- Conditions
- SLE (Systemic Lupus), Sjogren's Syndrome, Systemic Scleroderma, Dermatomyositis
- Trial name
- NCT06056921
- Testing
- CD19 targeted CAR-T cells
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Chongqing Precision Biotech Co., Ltd
Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies
Early Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases
Main purpose: To evaluate the safety of UTAA09 injection in the treatment of relapsed/refractory (R/R) autoimmune disease (AID).
- Conditions
- Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies, Systemic Sclerosis, IgG4 Related Disease
- Trial name
- NCT06361745
- Testing
- T cell injection targeting CD19 chimeric antigen receptor
- Where
- China
- Volunteers
- 10 people
- Sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Systemic Lupus Erythematosus
A Study of RJMty19 in Refractory Systemic Lupus Erythematosus (SLE)
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…
- Trial name
- NCT06340490
- Testing
- RJMty19 (CD19-CAR-DNT cells)
- Where
- 4 sites in China
- Volunteers
- 24 people
- Sponsor
- Guangdong Ruishun Biotech Co., Ltd
Lupus Nephritis
Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)
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…
- Trial name
- LUMINA (NCT07053800)
- Testing
- Obecabtagene autoleucel
- Where
- 15 sites in United States, Brazil and 3 more
- Volunteers
- 35 people
- Sponsor
- Autolus Limited
Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome
Universal CAR-T Cells (BRL-301) in Relapse or Refractory Autoimmune Diseases
This is an investigator initiated trial to assess the efficacy and safety of BRL-301 in the relapse or refractory autoimmune diseases of China.
- Conditions
- Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome, Systemic Sclerosis, Inflammatory Myopathy
- Trial name
- NCT05859997
- Testing
- BRL-301
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Bioray Laboratories