Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis

a study on Arthritis Rheumatoid Arthritis

Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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.

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

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.

Keywords

Rheumatoid Arthritis, safety, regulatory T cells, CART, Treg, Inflammatory disease, autoimmune disease, autologous, cell therapy, Arthritis, SBT777101

Eligibility

You can join if…

Open to people ages 18-70

  • Body mass index (BMI) <35 kg/m2, 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

You CAN'T join if...

  • 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

Locations

  • UCSF Medical Center accepting new patients
    San Francisco California 94143 United States
  • Stanford Medical Center accepting new patients
    Stanford California 94305 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Sonoma Biotherapeutics, Inc.
ID
NCT06201416
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 24 study participants
Last Updated
Contact us about this trial