Cyclophosphamide: Chemotherapy for Lymphodepletion
Study 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
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort — 28 days This primary endpoint will be used to evaluate safety and tolerability of AD1-001 in subjects with treatment-refractory RA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.