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

NCT06613360 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CLN-978-SL-101
• Study Type: interventional
• Target: 24
• Locations: 5 countries
• Sites: 15

Brief Summary

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

Conditions

SLE; SLE (Systemic Lupus)

Keywords

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

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

  48 weeks

Secondary Outcomes (3)

• Pharmacokinetics

  48 weeks

• Immunogenicity

  48 weeks

• Pharmacodynamics-related biomarker

  48 weeks

Other Outcomes (2)

• hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI)

  48 weeks

• Physicians Global Assessment

  48 weeks

Study Arms (2)

Part A Dose Escalation

EXPERIMENTAL

Patients with SLE 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 SLE

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

You may qualify if:

• 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 or in the previous 12 months before 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 ≥6 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 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
• 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.

You may not qualify if:

• 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 within 1 month 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.

Sponsors & Collaborators

• Cullinan Therapeutics Inc.: lead

Study Sites (15)

Cullinan Investigative Site

Avondale, Arizona, 85392, United States

RECRUITING

Cullinan Investigative Site

Tucson, Arizona, 85704, United States

RECRUITING

Cullinan Investigative Site

Orlando, Florida, 32808, United States

RECRUITING

Cullinan Investigative Site

Iowa City, Iowa, 52242, United States

RECRUITING

Cullinan Investigative Site

New York, New York, 10032, United States

RECRUITING

Cullinan Investigative Site

Rochester, New York, 14642, United States

RECRUITING

Cullinan Investigative Site

Memphis, Tennessee, 38163, 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, 84101, United States

RECRUITING

Cullinan Investigative Site

Parkville, Victoria, 3052, Australia

RECRUITING

Cullinan Investigative Site

Victoria Park, 6100, Australia

RECRUITING

Arensia Research Clinic

Sofia, Bulgaria

RECRUITING

Arensia Research Clinic

Tbilisi, Georgia

RECRUITING

Arensia Research Clinic

Chisinau, Moldova

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Meagan Sardinha

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: September 20, 2024
• First Posted: September 25, 2024
• Study Start: January 21, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

US (10); BU (1); GE (1); MO (1); AU (2)