A Phase 1 Study of ADI-001 in Rheumatoid Arthritis

Summary

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

Eligibility

Inclusion Criteria:

1. ≥ 18 years of age.
2. Fulfills the 2010 ACR-EULAR RA classification criteria
3. Agreement not to take traditional medicines and medications not prescribed by a doctor
4. Adequate hematological, liver, cardiac and pulmonary function

Exclusion Criteria:

1. Presence of severe liver disease, Child-Pugh class B or C.
2. Autoimmune disease requiring prednisone higher than 0.5 mg/kg/day (or corticosteroid equivalent).
3. Subjects unwilling to participate in an extended safety monitoring period (LTFU protocol)
4. 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.

Conditions2

Interventions3

Related trials

• A Phase 1 Study of FIT-CD19-CAR-T Cells in R/R B-ALL — TriArm Therapeutics (Taiwan) Limited
• A Phase I Clinical Study of IX001 TCR-T Injection in the Treatment of Advanced Pancreatic Cancer Patients With KRAS G12V Mutation — Sun Yat-sen University
• A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer — Shanghai JMT-Bio Inc.
• A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of Haplo-HSCT Using a TBI or TMLI Conditioning Regimen for Adult ALL — The First Affiliated Hospital of Zhengzhou University
• A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of Haplo-HSCT Using a TBI or TMLI Conditioning Regimen for Pediatric ALL — The First Affiliated Hospital of Zhengzhou University
• A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of MSD-HSCT Using a TBI or TMLI Conditioning Regimen for Adult ALL — The First Affiliated Hospital of Zhengzhou University
• A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of MSD-HSCT Using a TBI or TMLI Conditioning Regimen for Pediatric ALL — The First Affiliated Hospital of Zhengzhou University
• A Real-world Study of Obinutuzumab-based Therapy for Previously Untreated FL — Ruijin Hospital

Browse More Trials