Search / Trial NCT06613360

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

Launched by CULLINAN THERAPEUTICS INC. · Sep 23, 2024

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Trial Information

Current as of December 22, 2024

Recruiting

Keywords

Systemic Lupus Erythematosus

ClinConnect Summary

This clinical trial is studying a new treatment called CLN-978, which is designed to help people with moderate to severe Systemic Lupus Erythematosus (SLE). SLE is an autoimmune disease where the body’s immune system mistakenly attacks its own tissues, leading to various symptoms. The study is currently recruiting participants aged 18 years and older who have been diagnosed with SLE and have not responded well to at least two standard treatments. Eligible participants should have specific laboratory test results and active disease as indicated by a score on a disease activity scale.

If you join the trial, you will receive CLN-978 through an injection under the skin. The trial is in its early phase, meaning researchers are primarily focused on understanding the safety of this treatment and how well it works. Participants will be closely monitored for any side effects or changes in their condition. It’s important to know that certain health conditions or recent treatments may prevent someone from participating. Overall, this trial offers a potential new option for those struggling with SLE who have not had success with existing therapies.

Gender

ALL

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: 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 ≥8 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 CD19+ 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
  • • Serum albumin \>2.8 g/dL
  • • 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 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.

About Cullinan Therapeutics Inc.

Cullinan Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for cancer and other serious diseases. With a commitment to precision medicine, Cullinan leverages its proprietary platforms to identify and advance novel drug candidates that target unmet medical needs. The company’s multidisciplinary team combines expertise in drug development, molecular biology, and clinical research to drive projects from discovery through clinical trials, aiming to enhance patient outcomes and improve treatment paradigms. Cullinan Therapeutics is dedicated to fostering collaborations that accelerate the translation of scientific discoveries into effective therapeutic solutions.

Locations

Webster, Texas, United States

Orlando, Florida, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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