17 completed, 11 recruiting, 10 terminated, 4 not yet recruiting. 48 Phase 1, 21 Phase 2.
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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 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 |
| Allogeneic CD19/BCMA-Targeted CAR-γδT Cell Therapy: Safety and Preliminary Pharmacodynamics in Relapsed/Refractory Autoimmune Diseases Allogeneic CD19/BCMA-targeted CAR-γδT cell injection, Cyclophosphamide, Fludarabine - Refractory/Relapsed Systemic Lupus Erythematosus, Refractory / Relapsed / Progressive Systemic Sclerosis | Phase 1 | Not yet recruiting | Institute of Hematology & Blood Diseases Hospital, China | 9 | 2026-07-01 | 2026-06-09 |
| US Zamto-cel Autoimmune Diseases zamtocabtagene autoleucel, Cyclophosphamide, Fludarabine - Lupus Nephritis, Systemic Lupus Erythematosus | Phase 1 | Recruiting | Miltenyi Biomedicine GmbH | 48 | 2026-07-01 | 2026-06-11 |
| Controlling Hyperactive Immunity With Long-lived Lymphocytes QEL-005 - Diffuse Cutaneous Systemic Sclerosis, Rheumatoid Arthritis (RA) | Phase 1 / Phase 2 | Recruiting | Quell Therapeutics Limited | 16 | 2026-04-10 | 2026-10-19 |
| YTS109 in Pediatric Relapsed/Refractory Autoimmune Diseases YTS109 cell - Systemic Lupus Erythematosus (SLE), Diffuse Systemic Sclerosis | Phase 1 | Not yet recruiting | Children's Hospital of Fudan University | 12 | 2026-03-01 | 2026-02-27 |
| 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 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 Phase 1/2 Study of PRO-203 in Healthy Volunteers and Participants With Systemic Sclerosis. PRO-203, Placebo - Healthy Volunteers, Systemic Sclerosis (SSc) | Phase 1 / Phase 2 | Recruiting | Prolium Bioscience, Inc | 44 | 2025-10-27 | 2026-10-09 |
| A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases BMS-986515, Fludarabine, Cyclophosphamide - Refractory Autoimmune Diseases | Phase 1 | Recruiting | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | 125 | 2025-09-04 | 2026-07-14 |
| Efficacy and Safety of HN2301 in Autoimmune Diseases（AIDs） HN2301 injection - Systemic Lupus Erythematosus, Scleroderma | Phase 1 | Recruiting | Shenzhen MagicRNA Biotechnology Co., Ltd | 30 | 2025-03-16 | 2026-08-12 |
| 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 |
| A Study of CNTY-101 in Participants With Refractory B Cell-mediated Autoimmune Diseases CNTY-101, IL-2, Lymphodepleting Chemotherapy - Systemic Lupus Erythematosus, Lupus Nephritis | Phase 1 | Active not recruiting | Century Therapeutics, Inc. | 6 | 2025-02-06 | 2026-01-08 |
| Anti-CD19 CAR T-Cell Therapy in Refractory Systemic Autoimmune Diseases CAR T cell - Lupus Erythematosus, Systemic, System; Sclerosis | Phase 1 / Phase 2 | Recruiting | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | 8 | 2024-11-29 | 2025-04-11 |
| 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 |
| CARTIMMUNE: Study of Patients With Autoimmune Diseases Receiving KYV-101 KYV-101, Cyclophosphamide, Fludarabine - Idiopathic Inflammatory Myopathies, Diffuse Cutaneous Systemic Sclerosis | Phase 1 | Active not recruiting | David Porter | 24 | 2024-08-05 | 2026-09-21 |
| A Study of MK-2225 / ACE-1334 in Participants With Systemic Sclerosis With and Without Interstitial Lung Disease (MK-2225-002) MK-2225, Placebo - Systemic Sclerosis With and Without Interstitial Lung Disease | Phase 1 | Terminated | Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA | 5 | 2023-03-10 | 2023-11-24 |
| Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell IV Infusion for Systemic Sclerosis AlloRx - Systemic Sclerosis | Phase 1 | Terminated | The Foundation for Orthopaedics and Regenerative Medicine | 20 | 2022-07-04 | 2026-10-20 |
| A Safety and Efficacy Study of FCR001 in Adults With Rapidly Progressive Diffuse Cutaneous Systemic Sclerosis FCR001 - Diffuse Cutaneous Systemic Sclerosis | Phase 1 / Phase 2 | Withdrawn | Talaris Therapeutics Inc. | 2021-11-24 | 2023-10-12 |
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Scleroderma, Systemic (30) · Lupus Erythematosus, Systemic (10) · Myositis (9) · Autoimmune Diseases (8) · Lupus Nephritis (7) · Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (5) · Arthritis, Rheumatoid (5) · Dermatomyositis (5) · Polymyositis (3) · Sjogren's Syndrome (3) · Lung Diseases, Interstitial (2) · Scleroderma, Localized (2) · Sclerosis (2) · Acne Keloid (1)
Skin and Connective Tissue Diseases (48) · Connective Tissue Diseases (47) · Skin Diseases (47) · Scleroderma, Systemic (18) · Immune System Diseases (15) · Musculoskeletal Diseases (11) · Nervous System Diseases (10) · Neuromuscular Diseases (10) · Muscular Diseases (9) · Autoimmune Diseases (8) · Arthritis (7) · Cardiovascular Diseases (7) · Female Urogenital Diseases (7) · Female Urogenital Diseases and Pregnancy Complications (7) · Glomerulonephritis (7)
Cyclophosphamide (8) · fludarabine (8) · Mycophenolic Acid (2) · Tacrolimus (2) · Abatacept (1) · Biopsy (1) · Bone Marrow Transplantation (1) · Bosentan (1) · Brentuximab Vedotin (1) · Clobetasol (1) · Dabigatran (1) · Dasatinib (1) · Dimethyl Fumarate (1) · Drug Delivery Systems (1) · Flow Cytometry (1)
Boston University (3) · Bristol-Myers Squibb (3) · MedImmune LLC (2) · University of Michigan (2) · AbelZeta Inc. (1) · Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA (1) · Allogene Therapeutics (1) · Amgen (1) · CRISPR Therapeutics (1) · Castle Creek Biosciences, LLC. (1) · Century Therapeutics, Inc. (1) · Children's Hospital of Fudan University (1) · David Porter (1) · Fondazione Policlinico Universitario Agostino Gemelli IRCCS (1) · Fred Hutchinson Cancer Center (1)
United States (36) · Germany (4) · Australia (3) · Canada (3) · China (3) · France (3) · Spain (3) · Italy (2) · Netherlands (2) · Poland (2) · United Kingdom (2) · Antigua and Barbuda (1) · Argentina (1) · Belgium (1) · Brazil (1)
Robert Lafyatis, MD (4) · Brett King, MD, PhD (1) · Chadwick Prodromos, MD (1) · David Fox, MD (1) · Dinesh Khanna, MD (1) · Dinesh Khanna, MD, MSc (1) · Eliza Farmer Chakravarty (1) · Esther Eromosele, MD (1) · George Georges (1) · Jan T Gran, Professor (1)
PMID 19950289, PMID 23597147, PMID 24559157, PMID 26071192, PMID 26098215, PMID 27267753, PMID 28387950, PMID 29121645, PMID 30127049, PMID 30277862, PMID 35943798, PMID 40013233
2015 (1), 2025 (1), K23AR002187 (1), R01AI041721 (1), R21AR065089 (1), UM1AI109565 (1)