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A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Sjogren's Disease

Study Purpose

A phase 1b, open-label study of CLN-978 administered subcutaneously in patients with active, moderate to severe Sjogren's Disease.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion.

  • - Diagnosis of SjD at least 24 weeks prior to Screening Visit and meet the 2016 EULAR / ACR Classification Criteria for SjD at Screening.
  • - Have active moderate to severe disease (i.e., ESSDAI ≥5) at Screening.
  • - Laboratory parameters including the following: - Absolute lymphocyte count (ALC) ≥0.5 × 10^9/L.
  • - Peripheral CD19+ B cell count ≥25 cells/µL.
  • - Absolute neutrophil count (ANC) ≥1.0 × 10^9/L.
  • - Hemoglobin (Hgb) ≥8 g/dL.
  • - Platelet count ≥75 × 10^9/L.
  • - Total bilirubin ≤1.5 × ULN, except patients with confirmed Gilbert's Syndrome.
  • - Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.0 × ULN.
  • - Estimated glomerular filtration rate (eGFR) based on the CKD-EPI formula ≥30 mL/min/1.73 m2.
Exclusion.
  • - Concomitant rheumatological autoimmune disease.
  • - Considered at high risk for thrombosis.
  • - Rapidly progressive glomerulonephritis and/or urine protein/creatinine >3 mg/mg (339 mg/mmol).
  • - Active, severe central nervous system manifestations of SjD.
  • - History of stroke, seizure, dementia, Parkinson's disease, coordination movement disorder, cerebellar diseases, psychosis, paresis, aphasia, and any other neurologic disorder that the Investigator feels would put the patient at undue risk or confound study results.
  • - Evidence of hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), Epstein-Barr virus (EBV), or cytomegalovirus (CMV) infection.
  • - Primary immunodeficiency or history of recurrent infections.
  • - History of splenectomy.
  • - Live or attenuated vaccine within 28 days prior to the Screening Visit or during the Screening Period.
  • - Active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, within 14 days prior to Day 1.
- Active or latent tuberculosis (TB)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT07041099
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Cullinan Therapeutics Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Sjögren, Sjogren Disease, Sjogren's Syndrome
Arms & Interventions

Arms

Experimental: Part A Dose Escalation

Patients with Sjogren's Disease treated with CLN-978 in dose escalation cohorts

Experimental: Part B Further Dose Evaluation

Further evaluation of CLN-978 treatment of patients with Sjogren's Disease

Interventions

Drug: - CLN-978

Specified dose on specified days

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cullinan Investigative Site, Plano, Texas

Status

Recruiting

Address

Cullinan Investigative Site

Plano, Texas, 75093

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