Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis

Study Purpose

This study will test the safety and effects of SBT777101 when given as a single dose to subjects with rheumatoid arthritis. It is the first study of this treatment being done in humans. Increasing dose levels will be given after the safety at lower dose levels is shown.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Body mass index (BMI) <35 kg/m^2, inclusive.

- Adult-onset, moderate-to-severe rheumatoid arthritis (RA) - Moderate-to-severe active disease.

- Must have at least one joint that can be used for synovial biopsy.

- Confirmed presence of inflammatory cells and citrullinated proteins in synovial tissue.

- 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06201416
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Sonoma Biotherapeutics, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Mark Eisner, MD
Principal Investigator Affiliation	Sonoma Biotherapeutics, Inc.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Rheumatoid Arthritis

Additional Details

The study evaluates the safety and effects of a novel regulatory CARTreg cell-based autoimmune and inflammatory disease therapy for the treatment of rheumatoid arthritis. The therapy is an autologous (using the patient's own cells) Treg cell therapy that targets proteins in the inflamed, disease-associated tissue, with the aim to dampen inflammation and restore balance to the immune system.

Arms & Interventions

Arms

Experimental: SBT777101 Dose 1

Low dose SBT777101

Experimental: SBT777101 Dose 2

Mid dose SBT777101

Experimental: SBT777101 Dose 3

High dose SBT777101

Interventions

Biological: - SBT777101

Experimental treatment

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic, Scottsdale, Arizona

Status

Recruiting

Address

Mayo Clinic

Scottsdale, Arizona, 85259

Site Contact

Fawad Aslam, M.B.B.S., MS

[email protected]

480-301-8000

University of Colorado, Aurora, Colorado

Status