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The trial is taking place at:
O

Omega Research Group | Omega Research Orlando, LLC

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

C

Cullinan Therapeutics Inc.

Status and phase

Enrolling
Phase 1

Conditions

SLE
SLE (Systemic Lupus)

Treatments

Drug: CLN-978

Study type

Interventional

Funder types

Industry

Identifiers

NCT06613360
CLN-978-SL-101

Details and patient eligibility

About

Phase 1b, open-label study of CLN-978 administered subcutaneously in patients with Moderate to Severe Systemic Lupus Erythematosus (SLE).

Enrollment

24 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

24 participants in 2 patient groups

Part A Dose Escalation
Experimental group
Description:
Patients with SLE treated with CLN-978 in dose escalation cohorts
Treatment:
Drug: CLN-978
Part B Further Dose Evaluation
Experimental group
Description:
Further evaluation of CLN-978 treatment of patients with SLE
Treatment:
Drug: CLN-978

Trial contacts and locations

3

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Central trial contact

Meagan Sardinha

Data sourced from clinicaltrials.gov

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