Rheumatoid Arthritis study: SBT777101
Official title Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT06201416
What this study is testing
What is SBT777101?
an investigational autologous cell therapy being studied as a potential treatment for rheumatoid arthritis is designed to deliver the patient's own regulatory T cells that target inflamed joint tissue to dampen inflammation and help restore immune balance
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to learn whether SBT777101 is safe and well‑tolerated, how it behaves in the body, and whether it shows any early signs of helping rheumatoid arthritis.
- Who it's for
- Adults who have rheumatoid arthritis.
- What's involved
- Participants receive an intravenous infusion of the study drug (one dose, with higher doses tested later, and possibly a second dose about 6 weeks later). They will have clinic visits for the infusion and blood tests to check safety and drug levels.
- Time commitment
- The trial lasts several weeks, with visits for dosing and follow‑up, including up to a 6‑week interval if a split‑dose is given.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Scottsdale, Arizona, United States
- San Francisco, California, United States
- Stanford, California, United States
- Aurora, Colorado, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Portland, Oregon, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Scottsdale, Arizona, United States; San Francisco, California, United States; Stanford, California, United States; Aurora, Colorado, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States and 1 more location. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.