StudyFinder
MT2024-43: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects with Rheumatoid Arthritis
Status: Recruiting
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.
Sex: Male or Female
Age Group: 18 years and over
Inclusion Criteria:
• adult-onset, moderate-to-severe rheumatoid arthritis (RA)
• Body mass index (BMI) <35 kg/m^2
• inadequate response to or unable to tolerate available RA therapies
• willing to use highly effective methods of contraception
• see link to clinicaltrials.gov for complete inclusion criteria
Exclusion Criteria:
• major surgery within 12 weeks prior to screening or planned within 12 months
• uncontrolled heart, lung, kidney, liver, endocrine, or gastrointestinal disease
• recurrent infections or active infection
• see link to clinicaltrials.gov for complete exclusion criteria
Interventions:
Biological: SBT777101
Conditions:
Arthritis & Rheumatic Diseases, Immune Diseases
Keywords:
Autoimmune, Clinics and Surgery Center (CSC), RA, Rheumatoid Arthritis
Study Contact: Michelle Snyder - snyde003@umn.edu
Principal Investigator: Daniel Mueller
Phase: PHASE1
IRB Number: STUDY00023753
See this study on ClinicalTrials.gov