Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 3:20 PM
Study NCT ID:
NCT07391605
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-12
First Post:
2026-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Descartes-08 in Autoantibody Myositis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'C537778', 'term': 'Antisynthetase syndrome'}, {'id': 'D009220', 'term': 'Myositis'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2026-01-29', 'studyFirstSubmitQcDate': '2026-01-29', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major improvement of 2016 ACR/EULAR Total Improvement score', 'timeFrame': '24 weeks', 'description': 'Proportion of participants in the Descartes-08 group compared with placebo who achieve major improvement marked by ≥60 point improvement on the 2016 ACR/EULAR Total Improvement Score (TIS)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MYOSITIS', 'DESCARTES-08', 'MRNA CAR-T', 'TOTAL IMPROVEMENT SCORES', 'CDASI'], 'conditions': ['Antisynthetase Syndrome']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Fedak, R.R., Ruggerie, R.N., Shan, Y. et al. BCMA-directed mRNA CAR-T cell therapy for myasthenia gravis: exploratory biomarker analysis of a placebo-controlled phase 2b trial. Nat Med (2026). https://doi.org/10.1038/s41591-025-04170-z'}], 'seeAlsoLinks': [{'url': 'https://rdcu.be/e1nFI', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, placebo-controlled phase 2 study to evaluate the efficacy, safety and tolerability of an autologous T-cells expressing a chimeric antigen receptor (CAR) directed to B-Cell maturation antigen (BCMA) in patients with autoantibody-mediated myositis, including antisynthetase syndrome (ASyS) and dermatomyositis (DM).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of one of the following:\n\nDermatomyositis (DM): Probability score ≥55% on the 2017 EULAR/ACR (European Alliance of Associations of Rheumatology/ American College of Rheumatology) criteria for classification of dermatomyositis (corresponding to diagnosis of \'probable or definite\' DM). OR Antisynthetase Syndrome (ASyS): Diagnosis based on ACR/EULAR Classification Criteria (1)."\n\n* Participants must have dermatomyositis or antisynthetase syndrome with muscle and/or skin involvement.\n* Refractory or intolerance to standard therapy.\n* Stable background immunosuppressive therapy for ≥8 weeks.\n* Adequate hematologic, renal, hepatic, and pulmonary function (SpO₂ ≥92% on room air).\n* Informed consent, compliance with visits, contraception, and vaccinations required.\n\nExclusion Criteria:\n\n* Isolated interstitial lung disease (ILD) without muscle or skin involvement\n\n * Severe irreversible muscle damage or advanced weakness (e.g., wheelchair-bound).\n * Interstitial lung disease (ILD) requiring oxygen, severe pulmonary impairment (FVC ≤45%, DLCO ≤40%), or pulmonary hypertension.\n * Other inflammatory myopathies (PM, IMNM, IBM, cancer- or drug-induced myositis, overlap myositis except Sjögren\'s).\n * Other severe neuromuscular, cardiac, pulmonary, or systemic autoimmune diseases requiring immunosuppression.\n * Significant uncontrolled chronic illnesses or psychiatric conditions interfering with participation.\n * Pregnancy or lactation.\n * Recent use of prohibited immunosuppressants/biologics or investigational agents (per washout periods).\n * Live vaccination within 4 weeks.\n * History of primary immunodeficiency, organ or bone marrow transplant.\n * Active or uncontrolled infections: HBV, HCV, HIV, tuberculosis, or recurrent/severe infections.'}, 'identificationModule': {'nctId': 'NCT07391605', 'briefTitle': 'Descartes-08 in Autoantibody Myositis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cartesian Therapeutics'}, 'officialTitle': 'A Randomized Double-Blind Placebo-Controlled Study to Evaluate Efficacy, Safety, and Tolerability of Descartes-08 in Patients With Dermatomyositis and Antisynthetase Syndrome', 'orgStudyIdInfo': {'id': 'RNAC-TRITON-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Decartes-08', 'interventionNames': ['Drug: Descartes-08']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Descartes-08', 'type': 'DRUG', 'description': 'Autologous T-cells expressing a chimeric antigen receptor (CAR) directed to B-Cell maturation antigen (BCMA)', 'armGroupLabels': ['Decartes-08']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Plasma-Lyte', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Vera MD', 'role': 'CONTACT', 'email': 'trials@cartesiantx.com', 'phone': '6172318085'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cartesian Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}