Study of Single Doses of SBT777101 in Subjects With Hidradenitis Suppurativa

April 8, 2024 updated by: Sonoma Biotherapeutics, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SBT777101 Dose Level 1
Low dose SBT777101
Biological: SBT777101
Experimental treatment
Experimental: SBT777101 Dose Level 2
Mid dose SBT777101
Biological: SBT777101
Experimental treatment
Experimental: SBT777101 Dose Level 3
High dose SBT777101
Biological: SBT777101
Experimental treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence, nature, and severity of adverse events [Safety and Tolerability]
Time Frame: Day of treatment to end of follow-up period (48 weeks)
Day of treatment to end of follow-up period (48 weeks)
Incidence and nature of Dose Limiting Toxicities [DLTs]
Time Frame: Day of treatment to end of DLT evaluation period (28 days)
Day of treatment to end of DLT evaluation period (28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sonoma Biotherapeutics, Inc.

Investigators

  • Study Director: Mark Eisner, MD, 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 Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

April 8, 2024

First Submitted That Met QC Criteria

April 8, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBT777101-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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