Testing a new treatment for rheumatoid arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and effects of SBT777101, a novel regulatory T cell therapy, administered as a single dose to patients with moderate-to-severe rheumatoid arthritis. The approach involves using the patient's own Treg cells to target and reduce inflammation in affected tissues. The study will begin with lower doses to assess safety before escalating to higher doses. It represents the first human trial of this innovative treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Body mass index (BMI) \<35 kg/m\^2, inclusive
* Adult-onset, moderate-to-severe rheumatoid arthritis (RA)
* Moderate-to-severe active disease
* b/tsDMARD failure criterion (≥2)
* Swollen joint count ≥4
* Clinical and/or ultrasound evidence of synovitis
* Prior inadequate response to or unable to tolerate available RA therapies
* Stable doses of RA medications for at least 30 days
* Use of highly effective methods of contraception

Exclusion Criteria:

* Major surgery within 12 weeks prior to screening or planned within 12 months after dosing
* Uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease
* Recurrent infections or active infection
* Active or untreated latent tuberculosis
* Primary or secondary immunodeficiency
* History of or current inflammatory joint disease other than RA

Where it's running

• Mayo Clinic
  Scottsdale, Arizona, United States Recruiting
• UCSF Medical Center
  San Francisco, California, United States Recruiting
• Stanford Medical Center
  Stanford, California, United States Recruiting
• University of Colorado
  Aurora, Colorado, United States Recruiting
• Northwestern University
  Chicago, Illinois, United States Recruiting
• Tufts University
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Sabrina Fox-Bosetti, MPH
• Email: clinicaloperations@sonomabio.com
• Phone: 415-992-6245

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• GenAI-assisted RA bone erosion risk and DMARD choice

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• Telitacicept for difficult-to-treat rheumatoid arthritis

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  Recruiting Phase 2 Peking University People's Hospital · Hefei, Anhui and 46 other locations · NCT07796516

• PTC844 in people with active rheumatoid arthritis

  This study tests whether PTC844 is safe and how it behaves in the body compared with placebo for people with active rheumatoid arthritis.

  Recruiting at 6 sites Phase 2 PTC Therapeutics · Chandler, Arizona and 25 other locations · NCT07779616

• First-in-human test of CND319 in healthy people and people with rheumatic diseases

  This early study tests whether CND319 is safe and tolerable and whether it shows any signs of activity in healthy adults and in people with rheumatoid arthritis or Sjogren's syndrome.

  Recruiting Phase 1 Candid Therapeutics · Melbourne, Victoria · NCT07712939

• IV sarilumab for adults with rheumatoid arthritis

  This study tests IV sarilumab to see how it works and how safe it is for adults with moderately to severely active rheumatoid arthritis, with or without certain standard arthritis medicines.

  Recruiting at 12 sites Phase 1/2 Sanofi · Centennial, Colorado and 11 other locations · NCT07704580

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.