Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:26 AM
Study NCT ID:
NCT06613360
Status:
RECRUITING
Last Update Posted:
2025-11-26
First Post:
2024-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2024-09-20', 'studyFirstSubmitQcDate': '2024-09-23', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI)', 'timeFrame': '48 weeks', 'description': 'Change in hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) score on a scale of 0 to12 with a higher score meaning worse outcome'}, {'measure': 'Physicians Global Assessment', 'timeFrame': '48 weeks', 'description': 'Change in Physicians Global Assessment (PGA) score on a scale of 0 to 3 with a higher score indicating worse outcome'}], 'primaryOutcomes': [{'measure': 'Safety and tolerability', 'timeFrame': '48 weeks', 'description': 'Incidence and severity of adverse events (AEs)/adverse events of special interest (AESIs)/serious adverse events (SAEs)'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics', 'timeFrame': '48 weeks', 'description': 'Serum concentrations of CLN-978'}, {'measure': 'Immunogenicity', 'timeFrame': '48 weeks', 'description': 'Level of anti-drug antibodies'}, {'measure': 'Pharmacodynamics-related biomarker', 'timeFrame': '48 weeks', 'description': 'Levels of total B lymphocytes in the peripheral blood'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Systemic Lupus Erythematosus'], 'conditions': ['SLE', 'SLE (Systemic Lupus)']}, 'descriptionModule': {'briefSummary': 'Phase 1b, open-label study of CLN-978 administered subcutaneously in patients with Moderate to Severe Systemic Lupus Erythematosus (SLE).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of SLE at least 24 weeks prior to Screening and meet 2019 EULAR / ACR Classification Criteria at screening.\n* Presence of one or more of the following autoantibodies documented during screening or in the previous 12 months before screening: positive anti-nuclear antibody (ANA) test (≥1:80); anti dsDNA above the upper limit of normal (ULN); anti-Sm above the ULN.\n* Active SLE disease, as demonstrated by a SLEDAI total score ≥6 at screening.\n* Inadequate response to at least 2 of the following treatments: oral corticosteroid, antimalarials, conventional immunosuppressants, or biologics. At least one of the failed treatments should be an immunosuppressive or biologic standard-of care agent.\n* If on corticosteroid and/or antimalarial, the dose must be stable prior to day 1.\n* Laboratory parameters including the following:\n\n * Absolute lymphocyte count (ALC) ≥0.5 x 109/L\n * Peripheral B cell count ≥25 cells/µL\n * Absolute neutrophil count (ANC) ≥1.0 x 109/L\n * Hemoglobin ≥8 g/dL\n * Platelet count ≥75 x 109/L.\n * Estimated glomerular filtration rate (eGFR) (based on CKD-EPI formula) ≥30 mL/min/1.73m2\n * Total bilirubin ≤1.5 × ULN, except patients with confirmed Gilbert's Syndrome\n * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN\n* Part B only: For patients who were treated in Part A and did not experience dose-limiting toxicity (DLT) or discontinue CLN-978 treatment due to AEs are eligible for retreatment at a higher dose or longer schedule in Part B if they otherwise meet eligibility criteria and at least 90 days have passed since the last dose of CLN-978.\n\nExclusion Criteria:\n\n* Active inflammatory disease other than SLE. Thyroiditis or secondary Sjogren's syndrome is allowed.\n* Considered at high risk for thrombosis.\n* Rapidly progressive glomerulonephritis, and/or urine protein/creatinine \\>3 mg/mg (339 mg/mmol).\n* Active severe neuropsychiatric/CNS manifestations of SLE.\n* Evidence of hepatitis B, hepatitis C (HCV) infection, human immunodeficiency virus (HIV), Epstein-Barr virus (EBV), or cytomegalovirus (CMV) infection.\n* History of splenectomy.\n* Prior treatment with the following:\n\n * Cellular or gene therapy product directed at any target.\n * Investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to Day 1.\n * Any anti-CD19 or anti-CD20 therapy less than 3 months prior to Day 1.\n * Non-biologic DMARD within 14 days prior to Day 1.\n * Cyclophosphamide within 1 month or a biologic immunomodulating therapy during 2 months prior to Day 1.\n* Live or attenuated vaccine within 28 days prior to screening or during screening.\n* Active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection, including SARS-CoV-2 infection, within 14 days before Day 1.\n* Active or latent tuberculosis (TB) evidenced by a positive or indeterminant Interferon Gamma Release Assay (IGRA), unless the patient has documented previous completion of TB treatment and no current clinical indication of TB.\n* Any condition for which, in the opinion of the Investigator and/or Sponsor, would not be in the best interest of the patient to participate in the study or that could prevent, limit, or confound any protocol-defined assessment."}, 'identificationModule': {'nctId': 'NCT06613360', 'briefTitle': 'A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cullinan Therapeutics Inc.'}, 'officialTitle': 'A Phase 1b, Open-label, Pilot Study of CLN-978 for the Treatment of Moderate to Severe Systemic Lupus Erythematosus (SLE)', 'orgStudyIdInfo': {'id': 'CLN-978-SL-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A Dose Escalation', 'description': 'Patients with SLE treated with CLN-978 in dose escalation cohorts', 'interventionNames': ['Drug: CLN-978']}, {'type': 'EXPERIMENTAL', 'label': 'Part B Further Dose Evaluation', 'description': 'Further evaluation of CLN-978 treatment of patients with SLE', 'interventionNames': ['Drug: CLN-978']}], 'interventions': [{'name': 'CLN-978', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part A Dose Escalation', 'Part B Further Dose Evaluation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85392', 'city': 'Avondale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Cullinan Investigative Site', 'geoPoint': {'lat': 33.4356, 'lon': -112.3496}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Cullinan Investigative Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '32808', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Cullinan Investigative Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Cullinan Investigative Site', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Cullinan Investigative Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Cullinan Investigative Site', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '38163', 'city': 'Memphis', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Cullinan Investigative Site', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Cullinan Investigative Site', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '77598', 'city': 'Webster', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Cullinan Investigative Site', 'geoPoint': {'lat': 29.53773, 'lon': -95.11826}}, {'zip': '84101', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Cullinan Investigative Site', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '3052', 'city': 'Parkville', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Cullinan Investigative Site', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': '6100', 'city': 'Victoria Park', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Cullinan Investigative Site', 'geoPoint': {'lat': -31.97619, 'lon': 115.90525}}, {'city': 'Tbilisi', 'status': 'RECRUITING', 'country': 'Georgia', 'facility': 'Arensia Research Clinic', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Chisinau', 'status': 'RECRUITING', 'country': 'Moldova', 'facility': 'Arensia Research Clinic', 'geoPoint': {'lat': 47.00902, 'lon': 28.85938}}], 'centralContacts': [{'name': 'Meagan Sardinha', 'role': 'CONTACT', 'email': 'ClinOps@cullinantx.com', 'phone': '+1 617 410 4650'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cullinan Therapeutics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}