A Phase 1 Study of ADI-001 in Rheumatoid Arthritis
Recruiting · NCT07100873 · Interventional (participants receive a specific treatment) · Lead sponsor: Adicet Therapeutics
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
ADI-001-106 is a phase 1 study of ADI-001 with a randomized, single-blind, parallel group design to compare two different LD regimens in subjects with treatment-refractory RA. The study will consist of different periods including screening, LD, treatment, and follow-up
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- ≥ 18 years of age.
- Fulfills the 2010 ACR-EULAR RA classification criteria
- Agreement not to take traditional medicines and medications not prescribed by a doctor
- Adequate hematological, liver, cardiac and pulmonary function
Exclusion criteria
- Presence of severe liver disease, Child-Pugh class B or C.
- Autoimmune disease requiring prednisone higher than 0.5 mg/kg/day (or corticosteroid equivalent).
- Subjects unwilling to participate in an extended safety monitoring period (LTFU protocol)
- History of a clinically significant infection (including sepsis, pneumonia, bacteremia, fungal, viral and opportunistic infections) within 4 weeks prior to first dose of study drug which in the opinion of the Investigator may compromise the safety of the subject in the study.
Where it is running
1 location listed.
- Adicet Clinical Trials - Shanghai, Shanghai Municipality, China