9 not yet recruiting, 9 recruiting, 5 completed, 3 unknown. 32 Early Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Early Phase 1 | 32 | Not yet recruiting 9, Recruiting 9, Completed 5, Unknown 3, Active not recruiting 2, Suspended 2, Withdrawn 2 |
Follow Scleroderma, Systemic: new trials by email Literature Review of Scleroderma, Systemic trials Research Report on Scleroderma, Systemic
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Hyaluronidase for Sclerodactyly in Systemic Sclerosis Trial Hyaluronidase (Hylenex) - Systemic Sclerosis, Sclerodactyly | Early Phase 1 | Not yet recruiting | Medical University of South Carolina | 10 | 2026-11-01 | 2026-10-16 |
| Nebulized UC-EVs for Recurrent or Refractory IMIDs With Lung Involvement nebulized human umbilical cord mesenchymal stromal cell-derived extracellular vesicles - IgG4 Related Disease, Systemic Sclerosis (SSc) | Early Phase 1 | Not yet recruiting | Qiubai Li | 18 | 2026-10-14 | 2026-09-08 |
| CD19/BCMA-Targeted Universal CAR-T Cell Injection for the Treatment of Autoimmune Diseases RD06-05 CAR-T Cell Injection - SLE - Systemic Lupus Erythematosus, Systemic Sclerosis | Early Phase 1 | Not yet recruiting | Nanjing Bioheng Biotech Co., Ltd. | 30 | 2026-09-01 | 2026-07-16 |
| CD19/BCMA UCAR-T for B Cell-Related Autoimmune Disease QT-219CX - Autoimmune Diseases, Systemic Lupus Erthematosus (SLE) | Early Phase 1 | Recruiting | The Children's Hospital of Zhejiang University School of Medicine | 15 | 2026-05-08 | 2026-05-14 |
| A Study of BEN301 Injection in theTreatment of Autoimmune Diseases Single administration of 1x10^8 viable CD4+ CAR+ Foxp3+ cells., Single administration of 3x10^8 viable CD4+ CAR+ Foxp3+ cells. - Systemic Sclerosis (SSc), Rheumatoid Arthritis (RA) | Early Phase 1 | Suspended | RenJi Hospital | 24 | 2026-04-20 | 2026-06-04 |
| Allogeneic CD19/BCMA CAR-T for B Cell-Related Autoimmune Disease UCAR T-cell - Autoimmune Diseases, Systemic Lupus Erthematosus (SLE) | Early Phase 1 | Recruiting | The Children's Hospital of Zhejiang University School of Medicine | 15 | 2026-04-01 | 2026-04-02 |
| MTS109 in Patients With Refractory Autoimmune Diseases MTS109 - Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies | Early Phase 1 | Recruiting | Shanghai Changzheng Hospital | 15 | 2026-03-24 | 2026-06-30 |
| Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases anti-CD19/BCMA U CAR T cells - Autoimmune Diseases, Systemic Lupus Erythematosus | Early Phase 1 | Recruiting | Changhai Hospital | 60 | 2026-02-20 | 2026-02-25 |
| Clinical Study of BCT301 Cell Injection Therapy for Refractory Autoimmune Diseases BCT301 - System Lupus Erythematosus, Systemic Sclerosis (SSc) | Early Phase 1 | Recruiting | Peking University Third Hospital | 10 | 2025-12-11 | 2026-09-23 |
| the Safety and Efficacy of Targeted BCMA In Vivo LV Injection for Recurrent or Refractory Autoimmune Diseases V001-BCMA - Recurrent or Refractory Systemic Lupus Erythematosus, Recurrent or Refractory IgG4 Related Diseases | Early Phase 1 | Active not recruiting | Tongji Hospital | 45 | 2025-11-04 | 2026-09-17 |
| A Study of GB261 in Systemic Sclerosis Biological: GB261 - Systemic Sclerosis (SSc) | Early Phase 1 | Not yet recruiting | Ruijin Hospital | 10 | 2025-09-04 | 2025-09-08 |
| A Study of Cizutamig in Systemic Sclerosis Biological: cizutamig - Systemic Sclerosis (SSc) | Early Phase 1 | Not yet recruiting | Ruijin Hospital | 10 | 2025-09-04 | 2025-09-08 |
| GC012F in Patients With Autoimmune Diseases GC012F injection - Systemic Sclerosis (SSc), Idiopathic Inflammatory Myopathy (IIM) | Early Phase 1 | Not yet recruiting | Qiong Fu | 15 | 2025-08-18 | 2025-07-18 |
| A Study of LCAR-AIO in Subjects With Relapsed/Refractory Autoimmune Diseases LCAR-AIO T cells - Relapsed/Refractory Autoimmune Diseases | Early Phase 1 | Withdrawn | Nanjing Legend Biotech Co. | 2025-06-17 | 2025-07-08 | |
| Clinical Study on the Treatment of Systemic Sclerosis With UTAA91 Injection. UTAA91 injection - Systemic Sclerosis (SSc) | Early Phase 1 | Not yet recruiting | PersonGen BioTherapeutics (Suzhou) Co., Ltd. | 24 | 2025-06-01 | 2025-05-21 |
| The Clinical Study on the Treatment of SSc With UTAA91 Injection. UTAA91 injection - Systemic Sclerosis (SSc) | Early Phase 1 | Recruiting | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | 24 | 2025-05-30 | 2025-07-18 |
| Early Clinical Study of UTAA91 Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases UTAA91 injection - Systemic Lupus Erythematosus, Rheumatoid Arthritis | Early Phase 1 | Not yet recruiting | PersonGen BioTherapeutics (Suzhou) Co., Ltd. | 15 | 2025-05-18 | 2025-05-14 |
| Clinical Study on Targeted CD19/BCMA CAR-T Therapy for Autoimmune Diseases RD06-05 CART Cell Injection - SLE, Systemic Sclerosis | Early Phase 1 | Recruiting | Nanjing Bioheng Biotech Co., Ltd. | 18 | 2025-01-03 | 2026-02-02 |
| Safety Study of CC312 in Autoimmune Disease Patients CC312 - Systemic Lupus Erythematosus (SLE), Idiopathic Inflammatory Myopathy (IIM) | Early Phase 1 | Recruiting | CytoCares Inc | 18 | 2024-11-08 | 2025-09-17 |
| Clinical Study on Targeted CD19 or CD19-BCMA CAR-T Therapy for Autoimmune Diseases CD19 or CD19-BCMA CAR-T - SLE (Systemic Lupus), Systemic Sclerosis | Early Phase 1 | Recruiting | Nanjing Bioheng Biotech Co., Ltd. | 20 | 2024-09-14 | 2026-03-06 |
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Lupus Erythematosus, Systemic (13) · Myositis (12) · Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (11) · Autoimmune Diseases (9) · Sjogren's Syndrome (8) · Arthritis, Rheumatoid (5) · Scleroderma, Diffuse (5) · Antiphospholipid Syndrome (2) · Glomerulonephritis, IGA (2) · Immunoglobulin G4-Related Disease (2) · Microstomia (2) · Nephrotic Syndrome (2) · Purpura, Thrombocytopenic, Idiopathic (2) · Recurrence (2)
Connective Tissue Diseases (32) · Skin Diseases (32) · Skin and Connective Tissue Diseases (32) · Immune System Diseases (20) · Musculoskeletal Diseases (15) · Cardiovascular Diseases (13) · Muscular Diseases (13) · Nervous System Diseases (13) · Neuromuscular Diseases (13) · Skin Diseases, Vascular (13) · Vascular Diseases (13) · Arthritis (11) · Autoimmune Diseases (11) · Joint Diseases (11) · Rheumatic Diseases (11)
Hyaluronoglucosaminidase (2) · Antigens, CD19 (1) · Botulinum Toxins, Type A (1) · Buspirone (1) · Chondroitinases and Chondroitin Lyases (1) · Cyclophosphamide (1) · Lasers, Gas (1) · Methylprednisolone (1) · Methylprednisolone Hemisuccinate (1) · Radiotherapy, Intensity-Modulated (1) · Sodium Chloride (1) · Stem Cell Transplantation (1) · Therapeutics (1) · Whole-Body Irradiation (1)
Nanjing Bioheng Biotech Co., Ltd. (4) · PersonGen BioTherapeutics (Suzhou) Co., Ltd. (3) · Ruijin Hospital (2) · The Children's Hospital of Zhejiang University School of Medicine (2) · Brigham and Women's Hospital (1) · Changhai Hospital (1) · City of Hope Medical Center (1) · CytoCares Inc (1) · First Affiliated Hospital of Wenzhou Medical University (1) · Laikο General Hospital, Athens (1) · Medical University of South Carolina (1) · Nanjing Legend Biotech Co. (1) · Peking University Third Hospital (1) · Pontificia Universidad Catolica de Chile (1) · Qiong Fu (1)
China (19) · United States (4) · Chile (1) · Greece (1) · Netherlands (1) · South Korea (1)
Cristian Vera-Kellet, MD (1) · Georgios Karamanolis (1) · He Huang, PhD (1) · Heather Goff, MD (1) · Jeffrey Y Wong (1) · Jian Wu, Doctor (1) · LI Sun, Master's (1) · Madelon Vonk, Dr. (1) · Qiong Fu, Doctor (1) · Qiubai Li, MD (1) · Sarah L Lonowski, MD (1) · Seung-Ki Kwok (1) · Suk-Ho Moon, MD, PhD (1)
PMID 19819109, PMID 24034070, PMID 27586891, PMID 30134971, PMID 32611669, PMID 32961802, PMID 38552324