Rheumatoid Arthritis
Conditions
Keywords
rheumatoid arthritis, safety, regulatory T cells, CART, Treg, Inflammatory disease, autoimmune disease, autologous, cell therapy
Brief summary
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.
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 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.
Interventions
BIOLOGICALSBT777101
Experimental treatment
Sponsors
Sonoma Biotherapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Ascending Dose Cohorts (Cohorts 1-3) Split-Dose Cohort (Cohort 4)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Body mass index (BMI) \<35 kg/m\^2, inclusive * Adult-onset, moderate-to-severe rheumatoid arthritis (RA) * Moderate-to-severe active disease * b/tsDMARD failure criterion (≥2) * Swollen joint count ≥4 * Clinical and/or ultrasound evidence of synovitis * Prior inadequate response to or unable to tolerate available RA therapies * Stable doses of RA medications for at least 30 days * Use of highly effective methods of contraception
Exclusion criteria
* Major surgery within 12 weeks prior to screening or planned within 12 months after dosing * Uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease * Recurrent infections or active infection * Active or untreated latent tuberculosis * Primary or secondary immunodeficiency * History of or current inflammatory joint disease other than RA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Death, CRS, ICANS, vital organ toxicity, hematological toxicity |
Countries
United States
Contacts
CONTACTSabrina Fox-Bosetti, MPH
CONTACTJason Do
STUDY_DIRECTORSarah Baxter, MD, PhD
Sonoma Biotherapeutics, Inc.
Outcome results
None listed