A Study of CLN-978, a CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus

Launched by CULLINAN THERAPEUTICS INC. · Sep 23, 2024

Nctid: NCT06613360

Payload: {"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000008180", "term"=>"Lupus Erythematosus, Systemic"}], "ancestors"=>[{"id"=>"D000003240", "term"=>"Connective Tissue Diseases"}, {"id"=>"D000001327", "term"=>"Autoimmune Diseases"}, {"id"=>"D000007154", "term"=>"Immune System Diseases"}], "browseLeaves"=>[{"id"=>"M11177", "name"=>"Lupus Erythematosus, Systemic", "asFound"=>"Systemic Lupus Erythematosus", "relevance"=>"HIGH"}, {"id"=>"M6464", "name"=>"Connective Tissue Diseases", "relevance"=>"LOW"}, {"id"=>"M4629", "name"=>"Autoimmune Diseases", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NON_RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SEQUENTIAL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>24}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-11", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2027-12", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-23", "studyFirstSubmitDate"=>"2024-09-20", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "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 hSLEDAI score"}, {"measure"=>"Physicians Global Assessment", "timeFrame"=>"48 weeks", "description"=>"Change in PGA score"}], "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"=>false, "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: 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 ≥8 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 CD19+ 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 * Serum albumin \\>2.8 g/dL\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 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 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 Administered Subcutaneously 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"=>{"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"}}}}