Rheumatoid Arthritis (RAPhase 1NCT06994143
A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Rheumatoid Arthritis
A Phase 1 study testing CLN-978 in people with Rheumatoid Arthritis (RA, run by Cullinan Therapeutics Inc. at 4 sites in 2 countries.
Trial summary
A Phase I, open-label study of CLN-978 in patients with treatment-refractory rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis (RA
- What is being tested?
- CLN-978
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 19 May 2025to 30 Dec 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- Estimated glomerular filtration rate (eGFR) (based on the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) ≥30 mL/min/1.73m^2
- Total bilirubin ≤1.5 × ULN, except patients with confirmed Gilbert's Syndrome
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN
- Concurrent corticosteroids is permitted if the dose is ≤10 mg/day prednisone equivalent in the 2 weeks prior to initiation of study treatment. Hydroxychloroquine ≤400 mg/d or chloroquine ≤ 250 mg/d is allowed.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Germany2 sites, 2 recruiting
- Recruiting
University Hospital Erlangen
Erlangen, 91054
Nina Pfannschmidt, +49(0)91318536925
- Recruiting
University Hospital Heidelberg
Heidelberg, 69120
rheuma-studien.MED5@med.uni-heidelberg.de
Italy2 sites, 2 recruiting
- Recruiting
Fondazione Policlinico Universitario A Gemelli
Rome, 00168
Clinical Trial Office (Study Coordinator office), +39 06 3015 9650
- Recruiting
Humanitas Research Hospital
Rozzano, 20089
Elisa Gremese, MD, +39 0282247421, elisa.gremese@hunimed.eu
About this study
Official title: A Phase I, Open-Label Study of CLN-978 in Patients With Treatment-Refractory Rheumatoid Arthritis (RA)
A Phase I, open-label study of CLN-978 in patients with treatment-refractory rheumatoid arthritis.
- Conditions
- Rheumatoid Arthritis (RA
- Being tested
- CLN-978
- Keywords
- RA, Treatment-refractory RA
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLN-978Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part A: Dose Escalation | Experimental | Patients with RA treated with CLN-978 in dose escalation cohorts Receives: Drug: CLN-978 |
| Part B Further Dose Evaluation | Experimental | Further evaluation of CLN-978 treatment of patients with RA Receives: Drug: CLN-978 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events
Incidence and severity of adverse events (AEs)/adverse events of special interest (AESIs)/serious adverse events (SAEs)
Measured: 48 wks
Secondary outcomes (3)
Serum concentrations of CLN-978
Serum concentrations of CLN-978
Measured: 12 wks
Level of anti-drug antibodies
Level of anti-drug antibodies
Measured: 12 wks
Pharmacodynamics-related biomarker
Levels of total B lymphocytes in the peripheral blood
Measured: 48 wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start19 May 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cullinan Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994143
- Sponsor's protocol ID
- CLN-978-RA-101
- Status last verified
- May 2026
- First submitted
- 20 May 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No