Study of Single Doses of SBT777101 in Subjects With Hidradenitis Suppurativa

Last updated: April 24, 2025
Sponsor: Sonoma Biotherapeutics, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Hidradenitis Suppurativa

Rosacea

Scalp Disorders

Treatment

SBT777101

Clinical Study ID

NCT06361836
SBT777101-02
  • Ages 18-70
  • All Genders

Study Summary

This study will test the safety and effects of SBT777101 when given as a single dose to subjects with hidradenitis suppurativa. Increasing dose levels will be given after the safety at lower dose levels is shown.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Body mass index (BMI) ≤50 kg/m2, inclusive

  • Diagnosis of clinically active moderate-to-severe HS (Hurley Stage 2 or 3)

  • Total abscess or inflammatory nodule (AN) count of ≥5, affecting at least 2 distinctanatomic regions, with at least 1 accessible AN of adequate size for biopsy (diameter > 1 cm)

  • Total draining tunnel (dT) count of ≤20

  • Documented history of inadequate response or intolerance to at least a 3-monthcourse of 1 conventional systemic therapy (e.g., antibiotic) and 1 biologic drug (e.g., adalimumab or secukinumab)

  • Doses of medications for HS must be stable for at least 5 weeks prior to study drugadministration

  • Must agree to use highly effective method of contraception for at least 1 year postSBT777101 administration

Exclusion

Exclusion Criteria:

  • Major surgery within 12 weeks prior to screening or planned within 12 months afterdosing

  • History of or current inflammatory or other autoimmune disease

  • Complex presentations of HS

  • Skin disease other than HS that may confound clinical assessments or increasesubject risk in the study

  • Uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic,endocrine, or gastrointestinal disease

  • Active current infection or history of recurrent infections

  • Active or untreated latent tuberculosis

  • Primary or secondary immunodeficiency

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: SBT777101
Phase: 1
Study Start date:
October 09, 2024
Estimated Completion Date:
November 30, 2026

Study Description

The study evaluates the safety and effects of a novel regulatory CARTreg cell-based autoimmune and inflammatory disease therapy for the treatment of hidradenitis suppurativa. 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.

Connect with a study center

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

  • SLUCare Academic Pavillion

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • Duke University

    Durham, North Carolina 27708
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.