Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

— Regulate-RA  

Official title:

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects With Rheumatoid Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06201416
• Other study ID #: SBT777101-01
• Status: Recruiting
• Phase: Phase 1
• Start date: March 6, 2024
• Est. completion date: March 2026

Study information

• Verified date: May 2024
• Source: Sonoma Biotherapeutics, Inc.
• Contact: Sabrina Fox-Bosetti, MPH
• Phone: 415-992-6245
• Email: clinicaloperations[@]sonomabio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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

• Adult-onset, moderate-to-severe rheumatoid arthritis (RA)

• Moderate-to-severe active disease

• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• SBT777101
Experimental treatment

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Tufts University	Boston	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	Mayo Clinic	Scottsdale	Arizona
United States	Stanford Medical Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Sonoma Biotherapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence, nature, and severity of adverse events [Safety and Tolerability]		Day of treatment to end of follow-up period (48 weeks)
Primary	Incidence and nature of dose-limiting toxicities (DLTs)	Death, CRS, ICANS, vital organ toxicity, hematological toxicity	Day of treatment to end of DLT evaluation period (28 days)