15 recruiting, 13 completed, 8 terminated, 6 not yet recruiting. 51 Phase 1, 22 Phase 2.
Follow Systemic Sclerosis: new trials by email Literature Review of Systemic Sclerosis trials Research Report on Systemic Sclerosis
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 |
|---|---|---|---|---|---|---|
| C-CAR168, an Autologous Anti-CD20/BCMA Chimeric Antigen Receptor T-Cell Therapy, in Participants With Systemic Sclerosis (SSc) Refractory to Standard Therapy C-CAR168 - Systemic Sclerosis (SSc), Systemic Sclerosis | Phase 1 | Not yet recruiting | AbelZeta Inc. | 12 | 2027-03-01 | 2026-10-13 |
| A Study to Learn About a Medicine Called PF-08154225 in Participants With Autoimmune Diseases PF-08154225 - Systemic Lupus Erythematosus, Rheumatoid Arthritis | Phase 1 / Phase 2 | Not yet recruiting | Pfizer | 54 | 2026-11-19 | 2026-10-01 |
| A Study of BMS-986553 in Participants With Refractory Autoimmune Diseases BMS-986553 - Systemic Lupus Erythematosus, Sjögren's Disease | Phase 1 | Not yet recruiting | Bristol-Myers Squibb | 60 | 2026-10-30 | 2026-10-14 |
| A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body HBM7020 - Rheumatoid Arthritis, Systemic Lupus Erythematosus | Phase 1 | Recruiting | Otsuka Pharmaceutical Development & Commercialization, Inc. | 63 | 2026-09-24 | 2026-11-05 |
| A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy CD20/BCMA-directed CAR-T cells Autologous 2nd generation - Multiple Sclerosis (MS), Myasthenia Gravis (MG) | Phase 1 | Not yet recruiting | The Affiliated Hospital of Qingdao University | 18 | 2026-07-01 | 2026-06-30 |
| Umbilical Cord Blood CD19-BCMA CART Cell Therapy for SLE-LN, SSc, andpSS PAH. umbilical cord blood CD19-BCMA CAR-T cells infusion - Refractory Lupus Nephritis, Systemic Sclerosis | Phase 1 / Phase 2 | Recruiting | Beijing GoBroad Hospital | 45 | 2026-03-18 | 2026-03-03 |
| A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Autoimmune Diseases XmAb657 - Healthy, Idiopathic Inflammatory Myopathies | Phase 1 | Recruiting | Xencor, Inc. | 60 | 2026-02-24 | 2026-08-03 |
| A Study of AZD0120 in Autoimmune Diseases AZD0120, SOC - Systemic Sclerosis, Idiopathic Inflammatory Myopathies | Phase 1 / Phase 2 | Recruiting | AstraZeneca | 27 | 2026-01-09 | 2026-11-10 |
| Exploratory Clinical Study on YTS109 Cell Therapy for Autoimmune Diseases YTS109 cell - Systemic Lupus Erythematosus (SLE), Systemic Sclerosis | Phase 1 | Recruiting | China Immunotech (Beijing) Biotechnology Co., Ltd. | 18 | 2025-11-13 | 2026-03-02 |
| A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease ALLO-329, Cyclophosphamide, Fludarabine - Systemic Lupus Erythematosus (With and Without Nephritis), Idiopathic Inflammatory Myopathy | Phase 1 | Recruiting | Allogene Therapeutics | 66 | 2025-11-13 | 2026-11-02 |
| A Study of KITE-363 in Participants With Refractory Autoimmune Diseases KITE-363, Fludarabine, Cyclophosphamide - Systemic Lupus Erythematosus, Lupus Nephritis | Phase 1 | Enrolling by invitation | Kite, A Gilead Company | 52 | 2025-07-02 | 2026-09-28 |
| UCAR T-cell Therapy Targeting CD19/ BCMA in Patients With Relapse/ Refractory Autoimmune Diseases universal allogeneic anti-CD19/BCMA CAR T-cells - Systemic Lupus Erythematosus, Autoimmune Hemolytic Anemia | Phase 1 | Not yet recruiting | Changzhou No.2 People's Hospital | 18 | 2025-05-01 | 2025-05-18 |
| A Phase 1 Study of SYNCAR-001 + STK-009 Without Conditioning Chemotherapy (Lymphodepletion) in Subjects With Severe, Refractory Systemic Autoimmune Rheumatic Disease SYNCAR-001, STK-009 - Systemic Lupus Erythematosus, Lupus Nephritis | Phase 1 | Active not recruiting | Synthekine | 48 | 2025-04-29 | 2026-07-10 |
| CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH CD19-BCMA CAR-T cells infusion - Refractory Lupus Nephritis, Systemic Sclerosis | Phase 1 / Phase 2 | Recruiting | Beijing GoBroad Hospital | 45 | 2025-04-18 | 2026-07-30 |
| A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease CTX112 - SLE (Systemic Lupus), Lupus Erythematosus, Systemic | Phase 1 | Recruiting | CRISPR Therapeutics | 80 | 2025-03-10 | 2026-10-26 |
| Mesenchymal Stem Cells Infusion in Patients With Autoimmune Diseases Mesenchymal Stem Cells, Placebo - Rheumatoid Arthritis, Systemic Lupus Erythematosus (SLE) | Phase 1 / Phase 2 | Enrolling by invitation | National Institute of Blood and Marrow Transplant (NIBMT), Pakistan | 200 | 2025-02-01 | 2025-03-21 |
| A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2) NKX019, Fludarabine, Cyclophosphamide - Systemic Sclerosis, Idiopathic Inflammatory Myopathies | Phase 1 / Phase 2 | Recruiting | Nkarta, Inc. | 240 | 2024-11-04 | 2026-10-30 |
| KYSA-5: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Systemic Sclerosis KYV-101, Standard lymphodepletion regimen - Systemic Sclerosis, Systemic Sclerosis - Diffuse Cutaneous | Phase 1 / Phase 2 | Terminated | Kyverna Therapeutics | 3 | 2024-08-06 | 2026-08-31 |
| Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders Tafasitamab, Fludarabine phosphate, Cyclophosphamide - Autoimmune Disorders, Systemic Sclerosis | Phase 1 / Phase 2 | Recruiting | M.D. Anderson Cancer Center | 47 | 2024-07-31 | 2026-11-03 |
| Fourth-gen CAR T Cells Targeting BCMA/CD19 for Refractory Systemic Lupus Erythematosus (SLE) CD19- BCMA CAR-T cells - Systemic Lupus Erythematosus, Lupus Nephritis | Phase 1 / Phase 2 | Recruiting | Essen Biotech | 75 | 2024-07-10 | 2024-10-15 |
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Scleroderma, Systemic (51) · Lupus Erythematosus, Systemic (20) · Scleroderma, Diffuse (17) · Myositis (13) · Autoimmune Diseases (12) · Lupus Nephritis (9) · Arthritis, Rheumatoid (7) · Dermatomyositis (6) · Sjogren's Syndrome (6) · Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (5) · Arthritis, Juvenile (2) · Myasthenia Gravis (2) · Polymyositis (2) · Anemia, Hemolytic, Autoimmune (1) · Antiphospholipid Syndrome (1)
Skin Diseases (51) · Skin and Connective Tissue Diseases (51) · Connective Tissue Diseases (50) · Immune System Diseases (26) · Musculoskeletal Diseases (18) · Nervous System Diseases (18) · Neuromuscular Diseases (18) · Muscular Diseases (16) · Autoimmune Diseases (15) · Joint Diseases (12) · Rheumatic Diseases (12) · Arthritis (11) · Female Urogenital Diseases (9) · Female Urogenital Diseases and Pregnancy Complications (9) · Glomerulonephritis (9)
Cyclophosphamide (9) · fludarabine (8) · Alemtuzumab (2) · Leukapheresis (2) · Busulfan (1) · Dimethyl Fumarate (1) · Granulocyte Colony-Stimulating Factor (1) · Imatinib Mesylate (1) · Mesna (1) · Methotrexate (1) · Omeprazole (1) · Sirolimus (1) · Stem Cell Transplantation (1) · Ultraviolet Rays (1) · Valproic Acid (1)
Beijing GoBroad Hospital (2) · Jiangsu Renocell Biotech Company (2) · University of California, Los Angeles (2) · AbelZeta Inc. (1) · Allogene Therapeutics (1) · Amgen (1) · AstraZeneca (1) · Baylor College of Medicine (1) · Boston University (1) · Bristol-Myers Squibb (1) · CRISPR Therapeutics (1) · Changzhou No.2 People's Hospital (1) · China Immunotech (Beijing) Biotechnology Co., Ltd. (1) · Duke University (1) · Essen Biotech (1)
United States (28) · China (10) · Germany (6) · Spain (5) · Australia (4) · Belgium (3) · France (3) · Poland (3) · Argentina (2) · Canada (2) · Netherlands (2) · United Kingdom (2) · Antigua and Barbuda (1) · Belarus (1) · Chile (1)
Andrei Hancharou, Dr (1) · Ann Woolfrey (1) · Antonia Valenzuela, MD, MS (1) · Brett King, MD, PhD (1) · Carol A. Wallace, MD (1) · Chadwick Prodromos, MD (1) · Chitra Hosing, MD (1) · Cole Sterling, MD (1) · Daniel E. Furst, MD (1) · Dinesh Khanna, MD (1)
PMID 19950289, PMID 21769849, PMID 22542159, PMID 23597147, PMID 28724445, PMID 30127049, PMID 30277862, PMID 35943798, PMID 36997069, PMID 38206544, PMID 41501497, PMID 42177178
2015 (1), 2018 (1), 2023 (1)