RECRUITING

Study of Single Doses of SBT777101 in Subjects With Hidradenitis Suppurativa

Conditions

Hidradenitis Suppurativa regulatory T cells CAR T Treg autologous cell therapy autoimmune disease inflammatory disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-11

Study Completion:2026-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06361836

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 distinct anatomic 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-month course 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 drug administration * Must agree to use highly effective method of contraception for at least 1 year post SBT777101 administration	* Major surgery within 12 weeks prior to screening or planned within 12 months after dosing * History of or current inflammatory or other autoimmune disease * Complex presentations of HS * Skin disease other than HS that may confound clinical assessments or increase subject 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

Inclusion Criteria

Exclusion 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 distinct anatomic 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-month course 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 drug administration
* Must agree to use highly effective method of contraception for at least 1 year post SBT777101 administration

* Major surgery within 12 weeks prior to screening or planned within 12 months after dosing
* History of or current inflammatory or other autoimmune disease
* Complex presentations of HS
* Skin disease other than HS that may confound clinical assessments or increase subject 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

Contacts and Locations

Study Contact

Sabrina Fox-Bosetti, MPH

CONTACT

415-992-6245

clinicaloperations@sonomabio.com

Jason Do

CONTACT

415-992-6245

clinicaloperations@sonomabio.com

Principal Investigator

Joseph Arron, MD PhD

STUDY_DIRECTOR

Sonoma Biotherapeutics, Inc.

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

University of Minnesota

Minneapolis, Minnesota, 55455

United States

SLUCare Academic Pavillion

Saint Louis, Missouri, 63110

United States

Duke University

Durham, North Carolina, 27708

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Sonoma Biotherapeutics, Inc.

Joseph Arron, MD PhD, STUDY_DIRECTOR, Sonoma Biotherapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11

Study Completion Date2026-11

Study Record Updates

Study Start Date2024-11

Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

regulatory T cells
CAR T
Treg
autologous
cell therapy
hidradenitis suppurativa
autoimmune disease
inflammatory disease

Additional Relevant MeSH Terms

Hidradenitis Suppurativa