Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SBT777101.
- Who it may be relevant to
- Registry conditions: Rheumatoid Arthritis. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects With Rheumatoid Arthritis
Overview
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
- Biological SBT777101
Experimental treatment
Primary outcome measures
- 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)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 9 centers
- Mayo Clinic — Scottsdale
- UCSF Medical Center — San Francisco
- Stanford Medical Center — Stanford
- University of Colorado — Aurora
- Northwestern University — Chicago
- Tufts University — Boston
- Massachusetts General Hospital — Boston
- Brigham and Women's Hospital — Boston
- … and 1 more center
Identifiers
NCT: NCT06201416 · SBT777101-01