Study of Single Doses of SBT777101 in Subjects With Hidradenitis Suppurativa

NCT06361836 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: SBT777101-02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Hidradenitis Suppurativa

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Incidence, nature, and severity of adverse events [Safety and Tolerability]

  Day of treatment to end of follow-up period (48 weeks)

• Incidence and nature of Dose Limiting Toxicities [DLTs]

  Day of treatment to end of DLT evaluation period (28 days)

Study Arms (3)

SBT777101 Dose Level 1

EXPERIMENTAL

Low dose SBT777101

Biological: SBT777101

SBT777101 Dose Level 2

EXPERIMENTAL

Mid dose SBT777101

Biological: SBT777101

SBT777101 Dose Level 3

EXPERIMENTAL

High dose SBT777101

Biological: SBT777101

Interventions

SBT777101 BIOLOGICAL

Experimental treatment

SBT777101 Dose Level 1; SBT777101 Dose Level 2; SBT777101 Dose Level 3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sonoma Biotherapeutics, Inc.: lead

Study Sites (6)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

SLUCare Academic Pavillion

St Louis, Missouri, 63110, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Duke University

Durham, North Carolina, 27708, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases; Immune System Diseases

Study Officials

• Joseph Arron, MD PhD

  Sonoma Biotherapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sequential escalating dose cohorts

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 12, 2024
• Study Start: October 9, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)