{
  "data": {
    "asOf": "2026-10-30T22:25:18.212Z",
    "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only",
    "byRegistry": {
      "clinicaltrials_gov": 1
    },
    "canonicalTrial": {
      "canonicalId": "NCT06613360",
      "title": "A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus",
      "scientificTitle": "A Phase 1b, Open-label, Pilot Study of CLN-978 for the Treatment of Moderate to Severe Systemic Lupus Erythematosus (SLE)",
      "status": "recruiting",
      "studyType": "interventional",
      "phase": [
        "PHASE1"
      ],
      "conditions": [
        "SLE",
        "SLE (Systemic Lupus)"
      ],
      "interventions": [
        {
          "name": "CLN-978",
          "type": "DRUG",
          "description": "Specified dose on specified days"
        }
      ],
      "sponsor": {
        "name": "Cullinan Therapeutics Inc.",
        "type": "INDUSTRY"
      },
      "locations": [
        {
          "city": "Avondale",
          "country": "United States",
          "facility": "AARA Clinical Research"
        },
        {
          "city": "Tucson",
          "country": "United States",
          "facility": "AARA Clinical Research"
        },
        {
          "city": "Orlando",
          "country": "United States",
          "facility": "Omega Research Group"
        },
        {
          "city": "Iowa City",
          "country": "United States",
          "facility": "University of Iowa"
        },
        {
          "city": "Boston",
          "country": "United States",
          "facility": "Boston Children's Hospital"
        },
        {
          "city": "New York",
          "country": "United States",
          "facility": "NYU Grossman School of Medicine"
        },
        {
          "city": "New York",
          "country": "United States",
          "facility": "Columbia University Medical Center"
        },
        {
          "city": "Rochester",
          "country": "United States",
          "facility": "University of Rochester Medical Center"
        },
        {
          "city": "Memphis",
          "country": "United States",
          "facility": "Regional One Health"
        },
        {
          "city": "Plano",
          "country": "United States",
          "facility": "Stryde Research"
        },
        {
          "city": "Webster",
          "country": "United States",
          "facility": "Tranquil Clinical Research"
        },
        {
          "city": "Salt Lake City",
          "country": "United States",
          "facility": "Intermountain Health"
        },
        {
          "city": "Parkville",
          "country": "Australia",
          "facility": "Royal Melbourne Hospital"
        },
        {
          "city": "Victoria Park",
          "country": "Australia",
          "facility": "Osteoporosis Solutions"
        },
        {
          "city": "Sofia",
          "country": "Bulgaria",
          "facility": "Multi profile Hospital for Active Treatment Sveta Sofia"
        },
        {
          "city": "Nantes",
          "country": "France",
          "facility": "CHU de Nantes"
        },
        {
          "city": "Saint-Priest-en-Jarez",
          "country": "France",
          "facility": "University Hospital Saint Etienne"
        },
        {
          "city": "Toulouse",
          "country": "France",
          "facility": "Centre Hospitalier Universitaire de Toulouse"
        },
        {
          "city": "Tbilisi",
          "country": "Georgia",
          "facility": "ARENSIA Exploratory Medicine, LLC"
        },
        {
          "city": "Heidelberg",
          "country": "Germany",
          "facility": "Klinikum der Ruprecht-Karls Universitaet Heidelberg"
        },
        {
          "city": "Chisinau",
          "country": "Moldova",
          "facility": "Timofei Moșneaga Republican Clinical Hospital"
        },
        {
          "city": "Bucharest",
          "country": "Romania",
          "facility": "ARENSIA Exploratory Medicine S.R.L."
        },
        {
          "city": "Cluj-Napoca",
          "country": "Romania",
          "facility": "Arensia Exploratory Medicine"
        },
        {
          "city": "Seville",
          "country": "Spain",
          "facility": "Hospital Quironsalud Infanta Luisa"
        }
      ],
      "outcomes": {
        "other": [
          "hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI)",
          "Physicians Global Assessment"
        ],
        "primary": [
          "Safety and tolerability"
        ],
        "secondary": [
          "Pharmacokinetics",
          "Immunogenicity",
          "Pharmacodynamics-related biomarker"
        ]
      },
      "eligibility": {
        "sex": "ALL",
        "criteria": "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.",
        "maximumAge": "70 Years",
        "minimumAge": "18 Years",
        "healthyVolunteers": false
      },
      "enrollment": {
        "type": "ESTIMATED",
        "count": 24
      },
      "startDate": "2025-01-21",
      "completionDate": "2027-12-01",
      "lastUpdated": "2026-10-26T00:00:00.000Z",
      "firstPosted": "2024-09-25T00:00:00.000Z",
      "resultsAvailable": false,
      "sourceRegistries": [
        "clinicaltrials_gov"
      ],
      "sourceUrls": [
        "https://clinicaltrials.gov/study/NCT06613360"
      ]
    },
    "identifiers": [
      {
        "idType": "nct",
        "idValue": "NCT06613360",
        "declaredBy": "clinicaltrials_gov"
      }
    ],
    "sourceRecords": [
      {
        "registry": "clinicaltrials_gov",
        "registryName": "ClinicalTrials.gov",
        "license": "public-domain",
        "sourceId": "NCT06613360",
        "sourceUrl": "https://clinicaltrials.gov/study/NCT06613360",
        "sourceStatus": "RECRUITING",
        "retrievedAt": "2026-10-28T04:33:09.667Z",
        "payloadSha256": "68f4a3ed175fb791093551b17e192f51f85e7560ee981e50baa35dc2375db518",
        "piiRedacted": true
      }
    ],
    "citation": {
      "canonicalId": "NCT06613360",
      "sources": [
        {
          "registry": "clinicaltrials_gov",
          "registryName": "ClinicalTrials.gov",
          "license": "public-domain",
          "sourceId": "NCT06613360",
          "verifyAt": "https://clinicaltrials.gov/study/NCT06613360",
          "retrievedAt": "2026-10-28T04:33:09.667Z",
          "payloadSha256": "68f4a3ed175fb791093551b17e192f51f85e7560ee981e50baa35dc2375db518",
          "text": "ClinicalTrials.gov, record NCT06613360 (https://clinicaltrials.gov/study/NCT06613360), retrieved 2026-10-28, licence: public-domain."
        }
      ],
      "crossRegistry": false,
      "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only",
      "text": "Trial NCT06613360, registered in ClinicalTrials.gov, retrieved 2026-10-28. Verify at the source URLs listed; each retrieval is checksummed.",
      "note": "Only one registry is known to hold this trial. Absence from the others is not evidence it was not registered there."
    },
    "provenanceNote": "Personal contact fields (names, emails, phone numbers, addresses) are stripped from every stored payload. No participant-level data is collected or served."
  },
  "_meta": {
    "api": "The Last Economy Wire: World Trials API",
    "version": "1.0",
    "schemaVersion": "1",
    "correlationId": "req_PcbOpjq8v3-Z",
    "generatedAt": "2026-10-30T22:25:18.212Z",
    "documentation": "https://negativeresistance.com/embed",
    "license": "Free for any use. Attribution appreciated.",
    "degraded": false,
    "provenance": {
      "sources": [
        "clinicaltrials_gov"
      ],
      "attribution": {
        "clinicaltrials_gov": "ClinicalTrials.gov: licence: public-domain, https://clinicaltrials.gov/data-api/api-docs"
      },
      "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only",
      "limitations": [],
      "provenanceEndpoint": "/api/v1/sources"
    },
    "freshness": {
      "newestEvidenceAt": null,
      "lastSyncedAt": {
        "clinicaltrials_gov": "2026-10-28T04:33:30.663Z"
      },
      "degradedSources": [],
      "worldwide": false,
      "maxAgeHours": 65.9,
      "fromCache": false
    },
    "links": {
      "discovery": "https://negativeresistance.com/api/v1",
      "openapi": "https://negativeresistance.com/api/v1/openapi.json",
      "mcp": "https://negativeresistance.com/api/v1/mcp",
      "agentCard": "https://negativeresistance.com/.well-known/agent.json",
      "aiPlugin": "https://negativeresistance.com/.well-known/ai-plugin.json",
      "sdk": "https://negativeresistance.com/api/v1/sdk",
      "status": "https://negativeresistance.com/api/v1/status",
      "provenance": "https://negativeresistance.com/api/v1/sources",
      "contract": "https://negativeresistance.com/api/v1/contract",
      "curriculum": "https://negativeresistance.com/api/v1/curriculum",
      "graph": "https://negativeresistance.com/api/v1/graph",
      "openQuestions": "https://negativeresistance.com/api/v1/open-questions",
      "scoreboard": "https://negativeresistance.com/api/v1/scoreboard",
      "findings": "https://negativeresistance.com/api/v1/findings",
      "claims": "https://negativeresistance.com/api/v1/claims",
      "threads": "https://negativeresistance.com/api/v1/threads",
      "assignment": "https://negativeresistance.com/api/v1/assignment",
      "changes": "https://negativeresistance.com/api/v1/changes",
      "hello": "https://negativeresistance.com/api/v1/hello",
      "errors": "https://negativeresistance.com/api/v1/errors",
      "webhooks": "https://negativeresistance.com/api/v1/webhooks",
      "a2a": "https://negativeresistance.com/api/v1/a2a",
      "deadEnds": "https://negativeresistance.com/api/v1/dead-ends",
      "decompositions": "https://negativeresistance.com/api/v1/decompositions",
      "rungs": "https://negativeresistance.com/api/v1/rungs",
      "methods": "https://negativeresistance.com/api/v1/methods",
      "reality": "https://negativeresistance.com/api/v1/reality",
      "council": "https://negativeresistance.com/api/v1/council",
      "calibration": "https://negativeresistance.com/api/v1/calibration",
      "freshness": "https://negativeresistance.com/api/v1/freshness",
      "mission": "https://negativeresistance.com/api/v1/mission",
      "twin": "https://negativeresistance.com/api/v1/twin",
      "twinExperiment": "https://negativeresistance.com/api/v1/twin/experiment",
      "betaCell": "https://negativeresistance.com/api/v1/twin/beta-cell",
      "patientModel": "https://negativeresistance.com/api/v1/twin/patient-model",
      "agentCardCanonical": "https://negativeresistance.com/.well-known/agent-card.json",
      "collaborate": "https://negativeresistance.com/collaborate",
      "manifesto": "https://negativeresistance.com/about",
      "documentation": "https://negativeresistance.com/embed",
      "connect": "https://negativeresistance.com/connect",
      "llmsTxt": "https://negativeresistance.com/llms.txt",
      "llmsFullTxt": "https://negativeresistance.com/llms-full.txt"
    },
    "disclaimer": "Research data from public registries and literature; not medical advice."
  }
}