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Cancer Vaccine

SBT777101 for Hidradenitis Suppurativa (Regulate-HS Trial)

Phase 1
Recruiting
Research Sponsored by Sonoma Biotherapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day of treatment to end of follow-up period (48 weeks)
Awards & highlights

Summary

This trial will test a new drug, SBT777101, in people with hidradenitis suppurativa. The drug will be given in increasing doses to test its safety and effects.

Who is the study for?
This trial is for individuals with Hidradenitis Suppurativa, a skin condition characterized by painful lumps under the skin. Participants must meet certain health criteria to join, but specific inclusion and exclusion details are not provided.Check my eligibility
What is being tested?
The study is testing SBT777101, a new treatment given as a single dose to people with Hidradenitis Suppurativa. The trial will start at lower doses and increase only if those are shown to be safe.See study design
What are the potential side effects?
Since this is an early-stage trial for SBT777101, potential side effects aren't listed here. Generally, such trials monitor for any adverse reactions ranging from mild symptoms like headaches or nausea to more serious ones.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day of treatment to end of follow-up period (48 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day of treatment to end of follow-up period (48 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and nature of Dose Limiting Toxicities [DLTs]
Incidence, nature, and severity of adverse events [Safety and Tolerability]

Trial Design

3Treatment groups
Experimental Treatment
Group I: SBT777101 Dose Level 3Experimental Treatment1 Intervention
High dose SBT777101
Group II: SBT777101 Dose Level 2Experimental Treatment1 Intervention
Mid dose SBT777101
Group III: SBT777101 Dose Level 1Experimental Treatment1 Intervention
Low dose SBT777101

Find a Location

Who is running the clinical trial?

Sonoma Biotherapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
64 Total Patients Enrolled
Joseph Arron, MD PhDStudy DirectorSonoma Biotherapeutics, Inc.
Mark Eisner, MDStudy DirectorSonoma Biotherapeutics, Inc.
1 Previous Clinical Trials
24 Total Patients Enrolled
~16 spots leftby Jun 2026