About this trial
This is an open-label, multiple-dose escalation IIT clinical study aimed at evaluating the safety, tolerability, PK, and preliminary efficacy of STR-P004 in adult patients with relapsed or refractory autoimmune diseases.
Eligibility criteria
Qualifiers
Fully understand the purpose, nature, method of the trial and possible adverse reactions, voluntarily participate as a subject, and sign the informed consent form.
Aged ≥18 years (including the boundary value, based on the time of signing the informed consent form), male or female;
Diagnosed with Systemic Lupus Erythematosus (SLE) according to the 2019 European League Against Rheumatism (EULAR)/1997 American College of Rheumatology (ACR) classification criteria for diagnosis.
SLE-ITP: platelet count < 50×10^9/L in at least 2 consecutive blood routine tests; no obvious abnormalities in blood cell morphology by peripheral blood smear microscopy; bone marrow cell morphology consistent with immune thrombocytopenia; excluding thrombocytopenia caused by other non-SLE reasons, such as infection, bone marrow suppression, splenomegaly, hypersplenism, etc.; failed to achieve at least partial response after receiving at least 1 course of MP pulse therapy (1g×3 days) or high-dose hormone (1mg/kg/d equivalent glucocorticoid) combined with 1 or more immunosuppressants. Note: Complete Response (CR): platelet count ≥100×10^9/L; Partial Response (PR): platelet count 30-100×10^9/L, at least twice the pre-treatment level, and no bleeding.
Disqualifiers
Severe lupus nephritis within 8 weeks before screening (defined as urinary protein >6 g/24 hours or serum creatinine >2.5 mg/dL or 221 μmol/L), or need to use protocol-prohibited drugs to treat active nephritis, or need hemodialysis or receive prednisone ≥100 mg/d or equivalent glucocorticoid treatment for ≥14 days;
Central nervous system diseases caused by SLE or non-SLE within 8 weeks before screening (including but not limited to epilepsy, psychosis, interstitial encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis, etc.);
Other types of idiopathic inflammatory myopathies: inclusion body myositis, atrophic diabetes, juvenile myositis; patients with severe muscle damage or myositis with permanent weakness or cardiac involvement caused by non-IIM reasons (such as stroke);
SSc-related pulmonary hypertension requiring treatment; or rapidly progressive SSc-related lower gastrointestinal tract (small and large intestine) involvement (requiring parenteral nutrition), active gastric antral vascular ectasia; previous renal crisis caused by SSc;
Trial design
Treatments tested in this trial
- STR-P004
Treatment groups
Sponsors and collaborators
Beijing GoBroad Hospital
Lead sponsor
Starna Therapeutics
Collaborator