Study of Single Doses of SBT777101 in Subjects With Hidradenitis Suppurativa

Phase 1

Recruiting

• Conditions: Hidradenitis Suppurativa
• Interventions: Biological: SBT777101

• Registration Number: NCT06361836
• Lead 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 hidradenitis suppurativa. Increasing dose levels will be given after the safety at lower dose levels is shown.

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 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.

Study Timeline

• Study First Submitted: 2024-04-08
• Study First Submitted QC: 2024-04-08
• Study First Posted: 2024-04-12
• Study Start: 2024-10-09
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-27
• Primary Completion: 2026-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
SBT777101 Dose Level 2	SBT777101	Mid dose SBT777101
SBT777101 Dose Level 3	SBT777101	High dose SBT777101
SBT777101 Dose Level 1	SBT777101	Low dose SBT777101

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (6)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

SLUCare Academic Pavillion; 🇺🇸 Saint Louis, Missouri, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States