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SBT777101

Phase 1

Hidradenitis Suppurativa | Monoclonal antibody | Dermatology |Sonoma Pharmaceuticals, Inc.|Last Updated: Jun 30, 2026

Success Probability
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Market & Valuation
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Trial Design
CONTROLLEDDMC
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical trial landscape

SBT777101 · 2 trials · 2 indications

Phase 1 2
NCT06361836Study of Single Doses of SBT777101 in Subjects With Hidradenitis SuppurativaHidradenitis Suppurativa
ACTIVE NOT_RECRUITING24 Analytics
NCT06201416Study of Single Doses of SBT777101 in Subjects With Rheumatoid ArthritisRheumatoid Arthritis
RECRUITING48 Analytics
PHASE1ACTIVE NOT_RECRUITING
Study of Single Doses of SBT777101 in Subjects With Hidradenitis Suppurativa
Hidradenitis Suppurativa
NCT0636183624
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PHASE1RECRUITING
Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis
Rheumatoid Arthritis
NCT0620141648
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Study Endpoints
Primary Endpoints
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)
Incidence and nature of dose-limiting toxicities (DLTs)
Day of treatment to end of DLT evaluation period (28 days)

Death, CRS, ICANS, vital organ toxicity, hematological toxicity

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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SBT777101 Dose Level 1EXPERIMENTALLow dose SBT777101
SBT777101 Dose Level 2EXPERIMENTALMid dose SBT777101
SBT777101 Dose Level 3EXPERIMENTALHigh dose SBT777101
Cohort 1 - SBT777101 Dose 1EXPERIMENTALLow dose SBT777101
Cohort 2 - SBT777101 Dose 2EXPERIMENTALMid dose SBT777101
Cohort 3 - SBT777101 Dose 3EXPERIMENTALHigh dose SBT777101
Cohort 4 - SBT777101 Split-Dose AdministrationEXPERIMENTALParticipants receive two intravenous infusions of SBT777101 derived from a single manufacturing process. Total administered dose ranges from approximately 300 million to 900 million CAR+ Treg cells, divided across two administrations.
Interventions
NameTypeDescription
SBT777101BIOLOGICALExperimental treatment
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Eligibility Criteria
Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites6

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 b...

Countries:United States
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Competitive Landscape -Hidradenitis Suppurativa 38 trials
CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV5PHASE3Lutikizumab
Incyte CorporationINCY6PHASE3Povorcitinib
Novartis AG Sponsored ADRNVS12PHASE3secukinumab
MoonLake Immunotherapeutics Class AMLTX2PHASE3Sonelokimab
Sanofi SA Sponsored ADRSNY2PHASE2Brivekimig
Eli Lilly and CompanyLLY1PHASE2Eltrekibart
Pfizer Inc.PFE1PHASE2Ritlecitinib
Merck & Co., Inc.MRK1PHASE2Tulisokibart
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK1PHASE2Zasocitinib
Zura Bio Limited Class AZURA1PHASE2Tibulizumab Dose A, Tibulizumab Dose B
Sonoma Pharmaceuticals, Inc.SNOA2PHASE1SBT777101
Evommune, Inc.EVMN1EARLY_PHASE1EVO101
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Recent Changes (Last 90 Days)
LOWJul 5, 2026NCT06201416Enrollment: 24 → 48
LOWJul 5, 2026NCT06361836primaryCompletionDate: changed
LOWJul 5, 2026NCT06201416Enrollment: 24 → 48
LOWJul 5, 2026NCT06361836primaryCompletionDate: changed
LOWJul 5, 2026NCT06201416Enrollment: 24 → 48
LOWJul 5, 2026NCT06361836primaryCompletionDate: changed
LOWMay 24, 2026NCT06201416studyFirstPostDate: changed
LOWMay 24, 2026NCT06361836studyFirstPostDate: changed