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NCT06201416 | RECRUITING | Rheumatoid Arthritis

Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis
Sponsor:

Sonoma Biotherapeutics, Inc.

Brief 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.

Condition or disease

Rheumatoid Arthritis

Intervention/treatment

SBT777101

Phase

PHASE1

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 24 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2024-03-06
Estimated Primary Completion Date : 2026-03
Estimated Study Completion Date : 2026-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
  • * 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
Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis

Location Details

NCT06201416

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

Mayo Clinic

Scottsdale, arizona, United States, 85259

NOT YET RECRUITING

United States, California

Stanford Medical Center

Stanford, California, United States, 94305

RECRUITING

United States, Colorado

University of Colorado

Aurora, Colorado, United States, 80045

RECRUITING

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

RECRUITING

United States, Massachusetts

Tufts University

Boston, Massachusetts, United States, 02111

RECRUITING

United States, Massachusetts

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115