NCT06613360 A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus
| NCT ID | NCT06613360 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Cullinan Therapeutics Inc. |
| Condition | SLE |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-01-21 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2025-01-21 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Phase 1b, open-label study of CLN-978 administered subcutaneously in patients with Moderate to Severe Systemic Lupus Erythematosus (SLE).
Eligibility Criteria
Inclusion Criteria: * Diagnosis of SLE at least 24 weeks prior to Screening and meet 2019 EULAR / ACR Classification Criteria at screening. * 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. * Active SLE disease, as demonstrated by a SLEDAI total score ≥6 at screening. * 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. * If on corticosteroid and/or antimalarial, the dose must be stable prior to day 1. * Laboratory parameters including the following: * Absolute lymphocyte count (ALC) ≥0.5 x 109/L * Peripheral B cell count ≥25 cells/µL * Absolute neutrophil count (ANC) ≥1.0 x 109/L * Hemoglobin ≥8 g/dL * Platelet count ≥75 x 109/L. * Estimated glomerular filtration rate (eGFR) (based on CKD-EPI formula) ≥30 mL/min/1.73m2 * Total bilirubin ≤1.5 × ULN, except patients with confirmed Gilbert's Syndrome * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN * 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. Exclusion Criteria: * Active inflammatory disease other than SLE. Thyroiditis or secondary Sjogren's syndrome is allowed. * Considered at high risk for thrombosis. * Rapidly progressive glomerulonephritis, and/or urine protein/creatinine \>3 mg/mg (339 mg/mmol). * Active severe neuropsychiatric/CNS manifestations of SLE. * Evidence of hepatitis B, hepatitis C (HCV) infection, human immunodeficiency virus (HIV), Epstein-Barr virus (EBV), or cytomegalovirus (CMV) infection. * History of splenectomy. * Prior treatment with the following: * Cellular or gene therapy product directed at any target. * Investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to Day 1. * Any anti-CD19 or anti-CD20 therapy less than 3 months prior to Day 1. * Non-biologic DMARD within 14 days prior to Day 1. * Cyclophosphamide within 1 month or a biologic immunomodulating therapy during 2 months prior to Day 1. * Live or attenuated vaccine within 28 days prior to screening or during screening. * Active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection, including SARS-CoV-2 infection, within 14 days before Day 1. * 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. * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06613360 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying SLE. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06613360 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06613360 currently recruiting?
Yes, NCT06613360 is actively recruiting participants. Contact the research team at ClinOps@cullinantx.com for enrollment information.
Where is the NCT06613360 trial being conducted?
This trial is being conducted at Avondale, United States, Tucson, United States, Orlando, United States, Iowa City, United States and 11 additional locations.
Who is sponsoring the NCT06613360 clinical trial?
NCT06613360 is sponsored by Cullinan Therapeutics Inc.. The trial plans to enroll 24 participants.