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A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Rheumatoid Arthritis | Clinical Trials | Clareo Health

RECRUITINGPHASE1

A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Rheumatoid Arthritis

A Phase I, Open-Label Study of CLN-978 in Patients With Treatment-Refractory Rheumatoid Arthritis (RA)

NCT06994143•Cullinan Therapeutics Inc.

View on ClinicalTrials.gov

Summary

A Phase I, open-label study of CLN-978 in patients with treatment-refractory rheumatoid arthritis.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Documented diagnosis of RA which fulfills the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria ≥12 weeks prior to screening.
•Evidence of B-cell-driven disease at Screening or previous medical documentation, defined as either (i) seropositivity for RF and/or any AMPA and/or (ii) a synovial biopsy showing B-cell infiltration
•Active RA disease, as demonstrated by a DAS28 - ESR ≥3.2 and at least one swollen joint at screening.
•Inadequate response to at least 2 targeted treatments with different mechanisms. These can include tsDMARD and/or bDMARD, after failing conventional synthetic DMARD (unless contraindicated).
•Local laboratory assessments must meet the following criteria:
•* Absolute lymphocyte count (ALC) ≥0.5 x 10\^9/L
•* Peripheral CD19+ B cell count ≥25 cells/μL
•* Absolute neutrophil count (ANC) ≥1.0 x 10\^9/L
•* Hemoglobin (Hgb) ≥8 g/dL
•* Platelet count ≥75 x 10\^9/L
+4 more criteria

Exclusion Criteria

•Active inflammatory disease other than RA within 12 months prior to screening or during screening that may interfere with the study assessments. Thyroiditis or secondary Sjogren's syndrome is allowed.
•Clinical evidence of any other significant unstable or uncontrolled acute or chronic disease not due to RA which, in the opinion of the Investigator could put the patient at undue risk or confound study results.
•Prior treatment with the following:
•* Cellular therapy (e.g., chimeric antigen receptor T-cell (CAR-T) or gene therapy product directed at any target.
•* Receipt of an investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to Day 1 and during the study.
•* Received any anti-CD19 or anti-CD20 therapy such as blinatumomab, obinutuzumab, rituximab, ocrelizumab, or ofatumumab within 3 months prior to Day 1.
•* Non-biologic DMARD within 14 days prior to Day 1.
•* Cyclophosphamide or a biologic immunomodulating therapy within 2 months of Day 1.
•Live or live-attenuated vaccines within the 4 weeks prior to the Screening visit or during the Screening Period
•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.

Locations (2)

Cullinan Investigative Site

Erlangen, Germany

Cullinan Investigative Site

Rome, Italy

Key Dates

Start Date

May 19, 2025

Primary Completion Date

December 30, 2027

Completion Date

December 30, 2028

Last Updated

July 4, 2025

Enrollment

ESTIMATED participants

Conditions

Rheumatoid Arthritis (RA

Interventions

CLN-978

DRUG

Contacts

Amy Gubits, MPH

CONTACT

1 617 410 4650 ClinOps@cullinantx.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Rheumatoid Arthritis

Inclusion Criteria

Exclusion Criteria

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A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

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