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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 SuppurativaUnlock trial analytics
PHASE1RECRUITING
Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis
Rheumatoid ArthritisUnlock trial analytics

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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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

Frequently asked questions about SBT777101

What is SBT777101 used for?

SBT777101 is an investigational monoclonal antibody being developed for rheumatoid arthritis and hidradenitis suppurativa. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in adult patients with these conditions.

Who makes SBT777101?

SBT777101 is being developed by Sonoma Pharmaceuticals, Inc., a biopharmaceutical company. The company is conducting Phase 1 clinical trials for this investigational drug in the United States.

What phase is SBT777101 in?

SBT777101 is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. Two Phase 1 trials are ongoing, one in rheumatoid arthritis and one in hidradenitis suppurativa.

What clinical trials is SBT777101 in?

SBT777101 is being studied in two Phase 1 clinical trials. NCT06201416 is a single-dose study in subjects with rheumatoid arthritis, and NCT06361836 is a single-dose study in subjects with hidradenitis suppurativa. Both trials are being conducted in the United States.

Is SBT777101 the same as any other drug?

SBT777101 is a distinct investigational monoclonal antibody. No alternative names have been reported for this drug. It is being studied specifically for rheumatoid arthritis and hidradenitis suppurativa.