This is a single-arm, open-label, dose-escalation and dose-expansion clinical trial designed to evaluate the safety, efficacy, and cellular metabolism kinetics of GT801 in the treatment of moderate-to-severe refractory autoimmune diseases. Interim analysis will be conducted when 5 patients complete primary endpoint measurement.
1. The participant or their legal representative voluntarily signs a written informed consent form and is willing and able to comply with the study procedures.
2. Aged 18 to 65 years old (inclusive) at the time of signing the informed consent, regardless of gender.
a) Fulfill the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE.
b) Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2000) score ≥ 6, with at least one British Isles Lupus Assessment Group Index (BILAG-2004) Grade A (severe manifestation) or two Grade B (moderate manifestation) organ scores, or both; or SLEDAI-2000 score ≥ 8.
1. Participants with SLE
a. Drug-induced systemic lupus erythematosus.
b. Participants with lupus crisis; or those with concurrent diseases requiring the use of protocol-prohibited drugs, who are deemed ineligible for enrollment by the investigator.
2. Participants with IIM
Grit Biotechnology
Lead sponsor
Shanghai Changzheng Hospital
Collaborator