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

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