Study of Single Doses of SBT777101 in Subjects With Hidradenitis Suppurativa (Regulate-HS)

Sonoma Biotherapeutics

Status and phase: Enrolling; Phase 1

Conditions: Hidradenitis Suppurativa

Treatments: Biological: SBT777101

Study type: Interventional

Funder types: Industry

Identifiers

NCT06361836

SBT777101-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

SBT777101 Dose Level 1

Experimental group

Description:

Low dose SBT777101

Treatment:

Biological: SBT777101

SBT777101 Dose Level 2

Experimental group

Description:

Mid dose SBT777101

Treatment:

Biological: SBT777101

SBT777101 Dose Level 3

Experimental group

Description:

High dose SBT777101

Treatment:

Biological: SBT777101