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This study will test the safety and effects of SBT777101 when given as a single dose to subjects with rheumatoid arthritis. It is the first study of this treatment being done in humans. Increasing dose levels will be given after the safety at lower dose levels is shown. Following completion of the initial single ascending dose cohorts, the study may evaluate alternative administration regimens of SBT777101, including split-dose administration. In the split-dose cohort, participants may receive two intravenous infusions of SBT777101 derived from a single manufacturing process, administered approximately 6 weeks apart. The study will continue to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity.
The study evaluates the safety and effects of a novel regulatory CARTreg cell-based autoimmune and inflammatory disease therapy for the treatment of rheumatoid arthritis. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 - SBT777101 Dose 1 | Experimental | Low dose SBT777101 |
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| Cohort 2 - SBT777101 Dose 2 | Experimental | Mid dose SBT777101 |
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| Cohort 3 - SBT777101 Dose 3 | Experimental | High dose SBT777101 |
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| Cohort 4 - SBT777101 Split-Dose Administration | Experimental | Participants 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBT777101 | Biological | Experimental treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | Death, CRS, ICANS, vital organ toxicity, hematological toxicity | Day of treatment to end of DLT evaluation period (28 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sabrina Fox-Bosetti, MPH | Contact | 415-992-6245 | clinicaloperations@sonomabio.com | |
| Jason Do | Contact | 415-992-6245 | clinicaloperations@sonomabio.com |
| Name | Affiliation | Role |
|---|---|---|
| Sarah Baxter, MD, PhD | Sonoma Biotherapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Recruiting | Scottsdale | Arizona | 85259 | United States |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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Single Ascending Dose Cohorts (Cohorts 1-3) Split-Dose Cohort (Cohort 4)
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| UCSF Medical Center | Recruiting | San Francisco | California | 94143 | United States |
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| Stanford Medical Center | Recruiting | Stanford | California | 94305 | United States |
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| University of Colorado | Recruiting | Aurora | Colorado | 80045 | United States |
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| Northwestern University | Recruiting | Chicago | Illinois | 60611 | United States |
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| Tufts University | Recruiting | Boston | Massachusetts | 02111 | United States |
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| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
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| Oregon Health Sciences University | Recruiting | Portland | Oregon | 97239 | United States |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007154 | Immune System Diseases |