Recruiting

Phase 1

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

Sponsor:

Cullinan Therapeutics Inc.

Code:

NCT06613360

Conditions

SLE

SLE (Systemic Lupus)

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

CLN-978

Study Details

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)

Study ID

NCT06613360

Start date

Jan 21, 2025

Status verified date

Jun, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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 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.

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 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.
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

Enrollment

24 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

CLN-978

Specified dose on specified days

Primary outcome measure

Safety and tolerability [ Time Frame: 48 weeks ]

Central Contacts and Locations

Central contacts

Meagan Sardinha

+1 617 410 4650 ClinOps@cullinantx.com

Locations

AARA Clinical Research

Recruiting

Avondale, Arizona, United States, 85392

Contacts

Danaira Vasquez

602-386-4971 danaira.vasquez@aaracr.com

AARA Clinical Research

Recruiting

Tucson, Arizona, United States, 85704

Contacts

Mikayla Kirby

520-867-6906 Mikayla.Kirby@aaracr.com

Omega Research Group

Recruiting

Orlando, Florida, United States, 32808

Contacts

Audrey Treadway

386-668-4202 atreadway@omegarcllc.com

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Ashley Pieper

319-356-0765 ashley-pieper@uiowa.edu

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Contacts

Maria Allen

585-275-7167 maria_allen@urmc.rochester.edu

Regional One Health

Recruiting

Memphis, Tennessee, United States, 38103

Contacts

Kimberly Barbee

901-515-4520 kgbarbee@regionalonehealth.org

Stryde Research

Recruiting

Plano, Texas, United States, 75093

Contacts

Aarsheya Amin

214-884-7721 aamin@stryderesearch.com

Tranquil Clinical Research

Recruiting

Webster, Texas, United States, 77598

Contacts

Viswakanth Makutam

612-461-3159 sc@tranquilityresearch.com

Intermountain Health

Recruiting

Salt Lake City, Utah, United States, 84101

Contacts

Carrie Rhodes

801-408-4718 carrie.rhoades@imail.org

More Information

Sponsor

Cullinan Therapeutics Inc.

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

Keywords

Systemic Lupus Erythematosus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cullinan Therapeutics Inc. on 2026-06-05.