Hidradenitis SuppurativaPhase 1Regulate-HSNCT06361836
Study of Single Doses of SBT777101 in Subjects With Hidradenitis Suppurativa
A Phase 1 study testing SBT777101 in people with Hidradenitis Suppurativa, run by Sonoma Biotherapeutics, Inc. at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- SBT777101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 6 sitesUnited States
- Study dates
- 9 Oct 2024to Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Duke University
Durham, North Carolina, 27708
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of Minnesota
Minneapolis, Minnesota, 55455
Columbia University Irving Medical Center
New York, New York, 10032
SLUCare Academic Pavillion
St Louis, Missouri, 63110
About this study
Official title: 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.
Read the 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.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- SBT777101
- Keywords
- regulatory T cells, CAR T, Treg, autologous, cell therapy, hidradenitis suppurativa, autoimmune disease, inflammatory disease
- Medical subject headings
- Hidradenitis Suppurativa, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBT777101Biological
Experimental treatment
| Study group | Role | What they receive |
|---|---|---|
| SBT777101 Dose Level 1 | Experimental | Low dose SBT777101 Receives: Biological: SBT777101 |
| SBT777101 Dose Level 2 | Experimental | Mid dose SBT777101 Receives: Biological: SBT777101 |
| SBT777101 Dose Level 3 | Experimental | High dose SBT777101 Receives: Biological: SBT777101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, nature, and severity of adverse events [Safety and Tolerability]
Measured: Day of treatment to end of follow-up period (48 weeks)
Incidence and nature of Dose Limiting Toxicities [DLTs]
Measured: Day of treatment to end of DLT evaluation period (28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start9 Oct 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Sequential escalating dose cohorts
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sonoma Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Arron, MD PhD, Study director, Sonoma Biotherapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361836
- Sponsor's protocol ID
- SBT777101-02
- Acronym
- Regulate-HS
- Status last verified
- Feb 2026
- First submitted
- 8 Apr 2024
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects With Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT06361836
- Acronym / sponsor ID
- Regulate-HS / SBT777101-02
- Conditions
- Hidradenitis Suppurativa
- Keywords
- regulatory T cells, CAR T, Treg, autologous, cell therapy, hidradenitis suppurativa, autoimmune disease, inflammatory disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Sonoma Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Sequential escalating dose cohorts
| Arm | Type | Receives |
|---|---|---|
| SBT777101 Dose Level 1 | Experimental | Biological: SBT777101Low dose SBT777101 |
| SBT777101 Dose Level 2 | Experimental | Biological: SBT777101Mid dose SBT777101 |
| SBT777101 Dose Level 3 | Experimental | Biological: SBT777101High dose SBT777101 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBT777101Experimental treatment | Biological | SBT777101 Dose Level 1, SBT777101 Dose Level 2, SBT777101 Dose Level 3 |
Primary outcome
Incidence, nature, and severity of adverse events [Safety and Tolerability]
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Arron, MD PhD study director
Sonoma Biotherapeutics, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SBT777101 in people with Hidradenitis Suppurativa, run by Sonoma Biotherapeutics, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, nature, and severity of adverse events [Safety and Tolerability] (time frame: Day of treatment to end of follow-up period (48 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.