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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06613360




Registration number
NCT06613360
Ethics application status
Date submitted
20/09/2024
Date registered
25/09/2024
Date last updated
6/05/2025

Titles & IDs
Public title
A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus
Scientific title
A Phase 1b, Open-label, Pilot Study of CLN-978 for the Treatment of Moderate to Severe Systemic Lupus Erythematosus (SLE)
Secondary ID [1] 0 0
CLN-978-SL-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
SLE 0 0
SLE (Systemic Lupus) 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CLN-978

Experimental: Part A Dose Escalation - Patients with SLE treated with CLN-978 in dose escalation cohorts

Experimental: Part B Further Dose Evaluation - Further evaluation of CLN-978 treatment of patients with SLE


Treatment: Drugs: CLN-978
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability
Timepoint [1] 0 0
48 weeks
Secondary outcome [1] 0 0
Pharmacokinetics
Timepoint [1] 0 0
48 weeks
Secondary outcome [2] 0 0
Immunogenicity
Timepoint [2] 0 0
48 weeks
Secondary outcome [3] 0 0
Pharmacodynamics-related biomarker
Timepoint [3] 0 0
48 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/01/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2027
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Cullinan Investigative Site - Victoria Park
Recruitment postcode(s) [1] 0 0
- Victoria Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Iowa
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Georgia
State/province [5] 0 0
Tbilisi
Country [6] 0 0
Moldova, Republic of
State/province [6] 0 0
Chisinau

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cullinan Therapeutics Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Meagan Sardinha
Address 0 0
Country 0 0
Phone 0 0
+1 617 410 4650
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06613360