Recruiting
Phase 1

CLN-978

Sponsor:

Cullinan Therapeutics Inc.

Code:

NCT07041099

Conditions

Sjögren

Sjogren Disease

Sjogren's Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CLN-978

Study Details

Brief summary:

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

Conditions

Sjögren

Sjogren Disease

Sjogren's Syndrome

Study ID

NCT07041099

Start date

Oct 1, 2025

Status verified date

Aug, 2026

Completion date

Mar 15, 2029

Anticipated

Primary completion date

Mar 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

36 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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

CLN-978

Specified dose on specified days

Primary outcome measure

  • Safety and Tolerability [ Time Frame: 48 weeks ]

Central Contacts and Locations

Central contacts

Amy Gubits, MPH

+1 617 410 4650ClinOps@cullinantx.com

Locations

Omega Research

Recruiting

Orlando, Florida, United States, 32808

Contacts

Kwabena Ayesu, MD

407-512-1054kayesu@omegarcllc.com

New York University

Recruiting

Brooklyn, New York, United States, 11201

Contacts

Abraham Sinay-Smith

abraham.sinay-smith@nyulangone.org

Regional One

Recruiting

Memphis, Tennessee, United States, 38103

Contacts

Lisa McKnight

901-633-2531Lismith@regionalonehealth.org

Stryde Research

Recruiting

Plano, Texas, United States, 75093

Contacts

Mariana Paz

214-884-7787mpaz@stryderesearch.com

Tranquil Research

Recruiting

Webster, Texas, United States, 77598

Contacts

Karim Mohammed

713-907-6054sc@tranquilityresearch.com

Intermountain

Recruiting

Salt Lake City, Utah, United States, 84143

Contacts

Joshua Kunz

801-408-4724Joshua.kunz@imail.org

More Information

Sponsor

Cullinan Therapeutics Inc.

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Keywords

  • CLN-978

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-19. This information was provided to ClinicalTrials.gov by Cullinan Therapeutics Inc. on 2026-08-11.