Study of Single Doses of SBT777101 in Subjects With Hidradenitis Suppurativa

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06361836

Acronym

Regulate-HS

Enrollment

Registered

2024-04-12

Start date

2024-10-09

Completion date

2026-11-01

Last updated

2026-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hidradenitis Suppurativa

Keywords

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

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.

Interventions

BIOLOGICALSBT777101

Experimental treatment

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Sequential escalating dose cohorts

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
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)

Countries

United States

Contacts

STUDY_DIRECTORJoseph Arron, MD PhD

Sonoma Biotherapeutics, Inc.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026