Clinical trials: REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS
Systemic Lupus Erythematosus, Lupus
CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy, in Patients With Refractory Systemic Lupus Erythematosus (GALLOP)
This is a Phase 1 study to evaluate the safety and efficacy of a single infusion of CB-010 in patients with refractory Systemic Lupus Erythematosus (SLE) with cohorts for lupus nephritis (LN) and extrarenal lupus (ERL).
- Conditions
- Systemic Lupus Erythematosus, Lupus, Lupus Erythematosus, Lupus Nephritis
- Trial name
- GALLOP (NCT06752876)
- Testing
- CB-010
- Sponsor
- Caribou Biosciences, Inc.
Refractory Systemic Lupus Erythematosus
A Study of GC012F Injection in Subjects With Refractory Systemic Lupus Erythematosus
This is a single-arm, open-label, multicenter, phase 1/2 clinical study to assess the safety and efficacy of GC012F Injection in subjects with refractory Systemic Lupus Erythematosus (SLE).
- Trial name
- NCT06530849
- Testing
- GC012F Injection
- Where
- 2 sites in China
- Volunteers
- 20 people
- Sponsor
- Gracell Biotechnologies (Shanghai) Co., Ltd.
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
Lupus Nephritis, Systemic Lupus Erythematosus
US Zamto-cel Autoimmune Diseases
AID is a phase I multi-cohort study to assess the safety and tolerability of zamtocabtagene autoleucel (zamto-cel) in patients with refractory autoimmune diseases (SLE-Non renal, SLE-LN, SSc/dcSSc) after receiving standard…
- Conditions
- Lupus Nephritis, Systemic Lupus Erythematosus, Systemic Sclerosis (SSc), Diffuse Cutaneous Systemic Sclerosis
- Trial name
- NCT06708845
- Testing
- zamtocabtagene autoleucel, Cyclophosphamide, Fludarabine
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Miltenyi Biomedicine GmbH
Systemic Lupus Erythematosus
Study of CD19 CAR-T Therapy for Refractory SLE
This is an investigator-initiated trial aimed at assessing the safety and efficacy of PTOC1 cells Injection in the treatment of refractory systemic lupus erythematosus.
- Trial name
- NCT07403097
- Testing
- PTOC1
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Chongqing Precision Biotech Co., Ltd
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, 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.
Autoimmune Thrombocytopenia
Inaticabtagene Autoleucel Injection in the Treatment of Refractory Systemic Lupus Erythematosus-related Immune Thrombocytopenia
This is a single-arm, open-label，phase I clinical study to evaluate the safety and tolerability of Inaticabtagene Autoleucel Injection in treatment of refractory systemic lupus erythematosus-related immune thrombocytopenia.
- Trial name
- NCT06826430
- Testing
- Inaticabtagene autoleucel Injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Juventas Cell Therapy Ltd.
Inflammatory Diseases
Study of Efavaleukin Alfa in Healthy Chinese, Japanese, and Caucasian Participants
The primary objective of this study is to evaluate the pharmacokinetics (PK) of efavaleukin alfa after single subcutaneous (SC) administration in healthy Chinese, Japanese, and Caucasian participants.
- Trial name
- NCT04987333
- Testing
- Efavaleukin alfa
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Amgen
Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome (SS)
A Clinical Study of TI-0032-III Injection in Patients With Relapsed and Refractory Autoimmune Diseases
This is an open-label, dose escalation study in patients with relapsed and refractory autoimmune diseases. Study drug, TI-0032-III injection, is composed of lipid nanoparticles (LNPs) targeting T cells that encapsulate circular…
- Conditions
- Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome (SS), Systemic Sclerosis (SSc), Inflammatory Myopathy
- Trial name
- in vivo CAR-T (NCT07413341)
- Testing
- TI-0032-III injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Therorna
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.
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
Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus
A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
In this study, researchers will learn more about a study drug called BIIB059 (litifilimab) in participants with cutaneous lupus erythematosus (CLE).
- Trial name
- AMETHYST LTE (NCT06044337)
- Testing
- BIIB059 (litifilimab)
- Where
- 104 sites in United States, Argentina and 23 more
- Volunteers
- 306 people
- Sponsor
- Biogen
Refractory Autoimmune Diseases
A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases
The purpose of this study is to determine the safety, tolerability, optimal dose, and preliminary efficacy of BMS-986515, a healthy donor (HD) allogeneic CD19-targeted CART cell product, in participants with severe, refractory…
- Trial name
- NCT07115745
- Testing
- BMS-986515, Fludarabine, Cyclophosphamide
- Where
- 28 sites in United States, Australia and 8 more
- Volunteers
- 125 people
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Systemic Lupus Erthematosus (SLE)
KN5501 Cell Injection for Refractory SLE(CLEAR)
The goal of this clinical trial is to learn about the safety, pharmacokinetics and pharmacodynamics profile of KN5501 cell injection in adults with systemic lupus erythematosus(SLE).
- Trial name
- CLEAR (NCT07358988)
- Testing
- KN5501 cell injection
- Where
- 6 sites in China
- Volunteers
- 36 people
- Sponsor
- Ruitherapeutics Co., LTD
Systemic Lupus Erythematosus
Study of Ultra-Fast BCMA/CD70 CAR-T Therapy for Refractory SLE
This is an investigator-initiated trial aimed at assessing the safety and efficacy of ultra-fast autologous BCMA/CD70-targeted CAR-T cells in the treatment of refractory systemic lupus erythematosus.
- Trial name
- NCT07318259
- Testing
- BCMA/CD70 CAR-T cells
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Chongqing Precision Biotech Co., Ltd
Relapsed/Refractory Autoimmune Diseases
A Study of LCAR-AIO in Subjects With Relapsed/Refractory Autoimmune Diseases
This is a prospective, single-arm, open-label, dose-exploration and expansion clinical study of LCAR-AIO in adult subjects with relapsed/refractory autoimmune diseases.
- Trial name
- NCT06866080
- Testing
- LCAR-AIO T cells
- Where
- 4 sites in China
- Sponsor
- Nanjing Legend Biotech Co.
Systemic Lupus Erythematosus, Lupus Nephritis
An Open-label, Study to Assess Safety, Efficacy and Cellular Kinetics of YTB323 in Severe, Refractory Systemic Lupus Erythematosus
The study is intended to assess safety, efficacy and cellular kinetics of YTB323 treatment in participants with severe refractory systemic lupus erythematosus.
- Trial name
- NCT05798117
- Testing
- YTB323
- Where
- 10 sites in Australia, France and 3 more
- Volunteers
- 21 people
- Sponsor
- Novartis Pharmaceuticals
Systemic Lupus Erythematosus, Lupus Nephritis
A Study of KITE-363 in Participants With Refractory Autoimmune Diseases
This study will have two Phases: Phase 1a and Phase 1b. The goal of this clinical study is to learn more about the study drug KITE-363, to establish dosing, tolerability, safety, and preliminary efficacy of KITE-363 in…
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathy
- Trial name
- NCT07038447
- Testing
- KITE-363, Fludarabine, Cyclophosphamide
- Where
- 10 sites in United States, Australia and 2 more
- Volunteers
- 52 people
- Sponsor
- Kite, A Gilead Company
Systemic Lupus Erythematosus, Lupus Nephritis
UB-VV410 in Subjects With Active Refractory Systemic Lupus Erythematosus or Lupus Nephritis
This is an open-label investigator-initiated trial (IIT) to assess the safety, efficacy, and PK（pharmacokinetic）/PD（pharmacodynamics ） of UB-VV410 in adult subjects with clinically active treatment-refractory SLE.
- Trial name
- NCT07109986
- Testing
- UB-VV410
- Where
- China
- Volunteers
- 21 people
- Sponsor
- Nanjing IASO Biotechnology Co., Ltd.