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

NCT07041099 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CLN-978-SJ-101
• Study Type: interventional
• Target: 36
• Locations: 4 countries
• Sites: 11

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

Keywords

CLN-978

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability

  Incidence and severity of adverse events (AEs), serious AEs (SAEs), AEs of special interest (AESIs).

  48 weeks

Secondary Outcomes (3)

• To evaluate the PK of CLN-978

  48 weeks

• Detection of anti-drug antibodies

  48 weeks

• Change from baseline in B lymphocyte cell numbers in peripheral blood

  48 weeks

Study Arms (2)

Part A Dose Escalation

EXPERIMENTAL

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

Drug: CLN-978

Part B Further Dose Evaluation

EXPERIMENTAL

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

Drug: CLN-978

Interventions

CLN-978 DRUG

Specified dose on specified days

Part A Dose Escalation; Part B Further Dose Evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cullinan Therapeutics Inc.: lead

Study Sites (11)

Cullinan Investigative Site

Orlando, Florida, 32808, United States

RECRUITING

Cullinan Investigative Site

Memphis, Tennessee, 38103, United States

RECRUITING

Cullinan Investigative Site

Plano, Texas, 75093, United States

RECRUITING

Cullinan Investigative Site

Webster, Texas, 77598, United States

RECRUITING

Cullinan Investigative Site

Salt Lake City, Utah, 84107, United States

RECRUITING

Cullinan Investigative Site

Brest, 29609, France

RECRUITING

Cullinan Investigative Site

Le Kremlin-Bicêtre, 94270, France

RECRUITING

Cullinan Investigative Site

Strasbourg, 67098, France

RECRUITING

Cullinan Investigative Site

Erlangen, 91054, Germany

RECRUITING

Cullinan Investigative Site

Hanover, 30625, Germany

RECRUITING

Cullinan Investigative Site

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Amy Gubits, MPH

CONTACT

+1 617 410 4650; ClinOps@cullinantx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 27, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): March 15, 2028
• Study Completion (Estimated): March 15, 2029
• Last Updated: March 23, 2026

Record last verified: 2025-11

Locations

IT (1); DE (2); FR (3); US (5)