[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"idiopathic-inflammatory-myopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:idiopathic-inflammatory-myopathy":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,63,102],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100599485","phase-1-a-study-to-investigate-the-safety-and-preliminary-efficacy-of-allo-329-an-allogeneic-car-t-cell-therapy-in-adults-with-autoimmune-disease-100599485",false,"NCT07085104","A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease","A Phase 1 Study Evaluating the Safety and Preliminary Efficacy of ALLO-329, a Dual Anti-CD19\u002FAnti-CD70 Allogeneic CAR T Cell Product in Autoimmune Disease","RESOLUTION","Inclusion Criteria:\n\n1. Adults ≥ 18 to \\\u003C 70 years of age.\n2. Adequate hematological function and liver, cardiac, and pulmonary function.\n3. A highly sensitive urine pregnancy test or serum pregnancy test (for females of childbearing potential) negative at screening. All participants of childbearing potential must be willing to use a highly effective method of contraception for at least 12 months (6 months for males) after LD chemotherapy or ALLO-329 administration, whichever is later.\n4. Signed and dated informed consent form.\n5. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures.\n6. Confirmed active disease (SLE, IIM, or SSc) as defined by the appropriate classification criteria for each respective disease, clinical evidence, and\u002For laboratory testing.\n7. Disease activity as above despite prior treatment with standard of care therapy including at least one immunosuppressive agent for at least 3 months (in addition to hydroxychloroquine \\[HCQ\\]).\n\nExclusion Criteria:\n\n1. Participants with active systemic bacterial, fungal, or viral infection requiring systemic treatment or a clinically significant active, opportunistic, chronic or recurrent infection.\n2. Any active malignancy within 5 years prior to enrollment, except for adequately treated localized basal cell or squamous cell skin cancer, carcinoma in situ or low risk prostate cancer (Gleason score ≤ 6).\n3. Prior treatment with CD19 or CD70 targeted therapy or any prior engineered cell therapy (e.g., CAR T therapy).\n4. Clinically significant or unstable or uncontrolled acute or chronic disease (e.g., hypothyroidism and diabetes) not due to SLE\u002FIIM\u002FSSc.\n5. Symptomatic cardiac or vascular disease requiring medical intervention within 6 months prior to screening, hemodynamically symptomatic pericardial effusion, or symptomatic electrocardiogram abnormality requiring medical intervention.\n6. Child-Pugh Class B or C cirrhosis.\n7. Symptomatic airway disease requiring medical intervention, pleural effusion ≥ Grade 2, or history of pulmonary embolism requiring anticoagulant therapy within 6 months of enrollment.\n8. Participants known to be refractory to platelet or red blood cell transfusions or who will refuse indicated transfusion support to manage cell counts following treatment.\n9. Any form of primary, inherited immunodeficiency.\n10. Unwilling to participate in an extended safety monitoring period.\n11. For participants with SLE: Active disease involving CNS within the last 6 months or SLE that is drug-induced. For those with lupus nephritis, history of dialysis within 12 months or expected need for renal replacement therapy within the next 12 months, or National Institutes of Health (NIH) chronicity score of 3+ in any of the following domains: glomerular sclerosis, glomerular fibrous crescents, tubular atrophy, and\u002For interstitial fibrosis.\n12. Participants with IIM: A myositis other than IIM classification, non-reversible, unrelated or weakness not amenable to assessment, or dermatomyositis with presence of anti-TIF1 gamma antibody.\n13. Participants with SSc: Pulmonary arterial hypertension requiring treatment, rapidly progressive or severe SSc gastrointestinal involvement, or prior scleroderma renal crisis.","ALL","18 Years","69 Years",{"count":21,"type":22},66,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is a first-in-human, single-arm, open-label study evaluating the safety, tolerability, and preliminary efficacy of ALLO-329 in adults with autoimmune diseases: systemic lupus erythematosus (SLE) with and without renal involvement, idiopathic inflammatory myopathy (IIM), and systemic sclerosis (SSc).The purpose of this trial is to evaluate the safety and tolerability of ALLO-329, an allogeneic anti-CD19, anti-CD70 dual chimeric antigen receptor (CAR) T cell therapy, in adults with autoimmune disorders, provide initial evidence of biological activity and clinical response to the treatment and determine the recommended Phase 2 regimen (RP2R).",[28,29,30],"Systemic Lupus Erythematosus (With and Without Nephritis)","Idiopathic Inflammatory Myopathy","Systemic Sclerosis",[32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49],"Systemic lupus erythematosus","SLE","Lupus nephritis","LN","Idiopathic inflammatory myopathy","IIM","Myositis","Dermatomyositis","Anti-synthetase syndrome","Systemic sclerosis","Scleroderma","SSc","Autoimmune disease","CAR T","Allogeneic CAR T","CD19","CD70","AlloCAR T","RECRUITING","2026-06-17",{"date":53,"type":54},"2026-06-18","ACTUAL",{"date":56,"type":54},"2025-11-13",{"date":58,"type":22},"2032-10",{"name":60,"class":61},"Allogene Therapeutics","INDUSTRY",14,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":17,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":23,"phases":74,"briefSummary":77,"conditions":78,"keywords":85,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100527937","phase-2-reset-myositis-an-open-label-study-to-evaluate-the-safety-and-efficacy-of-caba-201-in-subjects-with-active-idiopathic-inflammatory-myopathy-or-juvenile-idiopathic-inflammatory-myopathy-100527937","NCT06154252","RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy","A Phase 1\u002F2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T Cells (CABA-201) in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy","Adult Cohorts\n\nInclusion Criteria:\n\n* Age ≥18 and ≤75\n* A clinical diagnosis of IIM, based on the 2017 The European League Against Rheumatism\u002FAmerican College of Rheumatology classification criteria\n* Diagnosis of DM, ASyS, or IMNM\n* Evidence of active disease, despite prior or current treatment with standard of care treatments, as defined by the presence of elevated creatine kinase (CK), DM rash, or active disease on muscle biopsy, magnetic resonance imaging (MRI), or electromyography\n* Presence of muscle weakness\n\nOther protocol-defined criteria apply.\n\nExclusion Criteria:\n\n* Contraindication to leukapheresis\n* History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide or any of their metabolites\n* Active infection requiring medical intervention at screening\n* Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections\n* Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures\n* Significant lung or cardiac impairment\n* Previous CAR T cell therapy\n* Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant\n\nOther protocol-defined criteria apply.\n\nJuvenile Cohort\n\nInclusion Criteria:\n\n* Age ≥6 and ≤17 years at enrollment\n* A clinical diagnosis of IIM, based on the 2017 The European League Against Rheumatism\u002FAmerican College of Rheumatology classification criteria\n* Evidence of active disease, despite prior or current treatment with standard of care treatments, as defined by the presence of elevated muscle enzymes, DM rash, or active disease on muscle biopsy, magnetic resonance imaging (MRI), or electromyography\n\nOther protocol-defined criteria apply.\n\nExclusion Criteria:\n\n* Contraindication to leukapheresis\n* History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide or any of their metabolites\n* Active infection requiring medical intervention at screening\n* Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections.\n* Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures\n* Significant lung or cardiac impairment\n* Previous CAR T cell therapy\n* Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant\n\nOther protocol-defined criteria apply.","6 Years","75 Years",{"count":73,"type":22},74,[75,76],"PHASE2","PHASE3","RESET-Myositis: Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects with Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy",[29,39,79,80,81,82,83,84],"Anti-Synthetase Syndrome","Immune-Mediated Necrotizing Myopathy","Juvenile Dermatomyositis","Juvenile Polymyositis","Juvenile Idiopathic Inflammatory Myopathy (JIIM)","Juvenile Myositis",[86,87,88,89,29,38,39,90,91,81,82,83,84],"CABA-201","Autoimmune Disease","Anti-CD19 CAR-T therapy","Cellular Therapy","Anti-synthetase Syndrome","Immune-mediated Necrotizing Myopathy","2026-06-08",{"date":94,"type":54},"2026-06-10",{"date":96,"type":54},"2023-12-20",{"date":98,"type":22},"2028-07",{"name":100,"class":61},"Cabaletta Bio",35,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":23,"phases":111,"briefSummary":112,"conditions":113,"keywords":116,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":128},"100506097","phase-1-a-study-of-cc-97540-cd-19-targeted-nex-t-car-t-cells-in-participants-with-severe-refractory-autoimmune-diseases-breakfree-1-100506097","NCT05869955","A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)","A Phase 1, Multicenter, Open-Label Study Of CC-97540 (BMS-986353), CD19-Targeted Nex-T Chimeric Antigen Receptor (CAR) T Cells, in Participants With Severe, Refractory Autoimmune Diseases: Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy, Systemic Sclerosis, or Rheumatoid Arthritis (Breakfree-1)","Inclusion Criteria\n\n\\- Diagnosis of Systemic Lupus Erythematosus (SLE) defined as follows:.\n\ni) Fulfilling the 2019 European League Against Rheumatism (EULAR) \u002F American College of Rheumatology (ACR) classification criteria of SLE.\n\nii) Presence of anti-dsDNA, anti-histone, anti-chromatin, anti-Ro (anti-SS-A), anti-La (anti-SS-B), or anti-Sm antibodies at screening.\n\n\\- SLE disease activity:.\n\ni) Active disease at screening, with recent ≥ 1 major organ system with a BILAG A score (excluding musculoskeletal, mucocutaneous, and\u002For constitutional organ system).\n\nii) Inadequate response to glucocorticoids and to at least 2 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolic acid or its derivatives, belimumab, azathioprine, anifrolumab, methotrexate, rituximab, obinutuzumab, cyclosporin, tacrolimus or voclosporin.\n\n* Diagnosis of Idiopathic Inflammatory Myopathy (IIM) defined as follows:.\n\n  i) Fulfilling the 2017 EULAR\u002FACR classification criteria for probable or definite IIM.\n\nii) Participant diagnosed with the following IIM subgroups: dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), anti-synthetase syndrome (ASyS), and polymyositis (PM).\n\niii) Presence of at least 1 myositis specific antibody (MSA), associated antibody (MAA), or ANA at screening or prior to screening.\n\n* IIM disease activity:.\n\n  i) Severe\u002Fmoderate muscle AND\u002FOR skin involvement.\n\nii) Proof of activity as documented by:.\n\nA. An active myositis-associated rash OR.\n\nB. A recent muscle biopsy OR.\n\nC. An elevated CK \\> 3 times the upper limit of normal OR.\n\nD. Participants diagnosed IIM AND progressive Interstitial Lung Disease (ILD) on high-resolution computed tomography (HRCT)\n\niii) Inadequate response to glucocorticoids and at least 2 of the following treatments used for at least 3 months: azathioprine, methotrexate, cyclosporin A, tacrolimus, MMF, cyclophosphamide, IVIG, JAK inhibitors, and rituximab.\n\n* Diagnosis of Systemic Sclerosis (SSc) defined as follows:.\n\n  i) Fulfilling 2013 EULAR\u002FACR classification criteria for SSc.\n\nii) Antinuclear Antibody (ANA) positive at screening or prior to screening.\n\n\\- SSc disease activity:.\n\ni) Participants diagnosed with diffuse cutaneous SSc OR diffuse or limited cutaneous SSc AND progressive ILD, AND.\n\nii) Inadequate response to at least 1 of the following treatments used for at least 3 months: mycophenolate, cyclophosphamide, rituximab, nintedanib, azathioprine, tocilizumab, or intravenous immunoglobulins (IVIG).\n\n\\- Rheumatoid Arthritis (RA) disease activity:.\n\ni) Minimum of 3 SJC and 3 TJC on a 66\u002F68 joint count (SJC\u002FTJC).\n\nii) OR participants diagnosed with progressive ILD (interstitial lung disease).\n\niii) AND Inadequate disease response or intolerance to at least one conventional synthetic disease-modifying antirheumatic drug (DMARD) and as well as ≥ 2 DMARDs with different mechanisms of action from the categories biologic disease-modifying antirheumatic drug (bDMARDs) or targeted synthetic disease-modifying anti-rheumatic drug (tsDMARD) for a minimum of 3 months.\n\nA. Participants qualifying on progressive ILD may have exhausted the therapies above OR have demonstrated inadequate disease response or intolerance to at least one of the following treatments used for at least 3 months: mycophenolate, tocilizumab, cyclophosphamide, rituximab, azathioprine, nintedinib, pirfenidone.\n\nExclusion Criteria\n\n\\- Diagnosis of drug-induced SLE rather than idiopathic SLE.\n\n\\- Other systemic autoimmune diseases (eg, multiple sclerosis, psoriasis, inflammatory bowel disease, etc) are excluded. Participants with type I autoimmune diabetes mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren's syndrome are not excluded.\n\n* SLE overlap syndromes including, but not limited to, rheumatoid arthritis, scleroderma, and mixed connective tissue disease, are excluded.\n* Present or recent clinically significant CNS pathology, within 12 months.\n* IIM disease activity:.\n\n  i) Other forms of IIM: Inclusion Body Myositis, Amyopathic DM, any form of juvenile myositis.\n\nii) Myositis other than IIM, eg, drug-induced myositis and PM associated with HIV.\n\niii) Participants with severe muscle damage (Physician VAS for muscle damage in Myositis Damage Index \\> 7 cm on a 10 cm scale), permanent weakness due to a non-IIM cause (eg, stroke), or myositis with cardiac involvement.\n\n\\- SSc disease activity:.\n\ni) SSc related PAH requiring active treatment.\n\nii) Rapidly progressive SSc related lower GI (small and large intestines) involvement (requiring parenteral nutrition); active gastric antral vascular ectasia.\n\niii) Prior scleroderma renal crisis.\n\n\\- RA disease activity:.\n\ni) Prior history of or current inflammatory joint disease other than RA.\n\nii) Joint damage and\u002For deformity that may confound the investigator's ability to accurately assess disease activity.\n\n\\- Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":110,"type":22},270,[25],"The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory autoimmune diseases (Breakfree-1).",[114,29,30,115],"Systemic Lupus Erythematosus","Rheumatoid Arthritis",[117,118],"CC-97540","BMS-986353","2026-06-02",{"date":121,"type":54},"2026-06-03",{"date":123,"type":54},"2023-09-13",{"date":125,"type":22},"2028-08-29",{"name":127,"class":61},"Juno Therapeutics, Inc., a Bristol-Myers Squibb Company",54]